Shah Permavent
510(k) K974007
Shah Permavent is a medical device (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Exmoor Plastics Limited, cleared under FDA 510(k) K974007 on 12 Dec 1997, active as of 13 Nov 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 | NumberK974007 | Date12 Dec 1997 | StatusActive |
Official records
- FDA 510(k) database K974007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- ETD
- FDA applicant
- Exmoor Plastics , Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 874.3880
- Advisory committee
- Ear, Nose, Throat
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code ETD (Tube, Tympanostomy).
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- GYRUS ACMI 70245017 by Gyrus Acmi, Inc.
- SILVERSTEIN MICROWICK by Micromedics, Inc.
- OTOLOGICAL VENTILATION TUBES by Mcghan Medical Corp.
- GROMMET STYLE VENTURI by River Medical, Inc.
- PRO-000-311 by Summit Medical, LLC
- GOODE T-TUBE WHITE SILICONE TYMPANOSTOMY TUBE by Xomed, Inc.
- TYMPANOSTOMY TUBES & VARIOUS TYPES by Kelleher Corp.
- COLLAR BUTTON VENT TUBE by Treace Medical, Inc.
- BOBBIN STYLE VENTURI by River Medical, Inc.