RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE
FDA 510(k) clearance K913893 · decided 1992-10-23
Clearance details
- K-number
- K913893
- Device name
- RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE
- Applicant
- Depuy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-30
- Decision date
- 1992-10-23
- Days to decision
- 420 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
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| LCS Total Knee System (P830055/S348) | Depuy, Inc. | 2025-08-29 |