SURGICAL UTILITY DRAPE
FDA 510(k) clearance K821313 · decided 1982-06-21
Clearance details
- K-number
- K821313
- Device name
- SURGICAL UTILITY DRAPE
- Applicant
- Megaplast, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-05-04
- Decision date
- 1982-06-21
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- FJZ
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, 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 SURGICAL DRAPES (K821666) | Phoenix Glove Co. | 1982-06-21 |
| DECOLLATING TRAY (K760995) | Dravon Medical, Inc. | 1977-01-06 |
Recalls involving this device
No recalls on record reference this clearance.