THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE
FDA 510(k) clearance K851675 · decided 1985-05-14
Clearance details
- K-number
- K851675
- Device name
- THE PERCUTANEOUS NEPHROSTOLITHOTOMY DRAPE
- Applicant
- Lingeman Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-23
- Decision date
- 1985-05-14
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- EYY
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| STERILE/DISPOSABLE HSG TRAY (K810291) | Unimar, Inc. | 1981-03-18 |
Recalls involving this device
No recalls on record reference this clearance.