Mega Dressing Change Kit
by Megadyne Medical Products, Inc.
510(k) K910363
Mega Dressing Change Kit is a Class II device made by Megadyne Medical Products, Inc., cleared under FDA 510(k) K910363 on 28 Mar 1991, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK910363 | Date28 Mar 1991 | StatusActive |
Official records
- FDA 510(k) database K910363
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MCY
- Device class
- Class II
- Regulation
- 21 CFR Part 880.5075
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code MCY (Wound Dressing Kit).
- ROUTINE DRESSING TRAY by Orion Life Systems, Inc.
- WOUND DRESSING KIT by Kit Pak, Inc.
- CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY by Grand Medical Products
- E-PACK PROCEDURE KITS by Ethicon Inc.
- Circulon System Step 2 by Convatec, A Division of E.R. Squibb & Sons
- VARIOUS NON-STERILE CUSTOM TRAYS/KITS by Surgipro Central, Inc.
- Wound Care Compression System (WCCS) by Suncoast Medical Products, Inc.
- ULCERCARE by Jobst Institute, Inc.
- TPN TRAY (STERILE) by Customed, Inc.
- PRESSURE SORE MANAGEMENT KIT by Medical Device Inspection Co., Inc.