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Emm Surgical Gown-Sms With Pe Layer (18-501 L +3 more)
FDA 510(k)Class II (US FDA 510(k))
510(k) K101593
Identifiers
- 510(k) Number
- K101593 FDA 510(k)
- FDA Product Code
- FYA FDA 510(k)
- Models / Variants
- 18-501 L FDA 510(k)18-501-Xl FDA 510(k)18-501 Xxl FDA 510(k)18-501-Xlxl FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Emm Surgical Gown-Sms With Pe Layer (18-501 L +3 more) by Exact Medical Manufacturing, Inc — Class II — FDA_510K — listed in FDA 510(k) — 4 models
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101593 | Class II | Active |
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Manufacturer
- Manufacturer
- Exact Medical Manufacturing, Inc
- FDA Applicant
- Exact Medical Manufacturing, Inc.
Sources (1)
- FDA 510(k) K101593 24 fields · synced Jun 18, 2026