STERILE SURGICAL DRAPES
FDA 510(k) clearance K821666 · decided 1982-06-21
Clearance details
- K-number
- K821666
- Device name
- STERILE SURGICAL DRAPES
- Applicant
- Phoenix Glove Co.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-07
- Decision date
- 1982-06-21
- Days to decision
- 14 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 |
|---|---|---|
| SURGICAL UTILITY DRAPE (K821313) | Megaplast, Inc. | 1982-06-21 |
| DECOLLATING TRAY (K760995) | Dravon Medical, Inc. | 1977-01-06 |
Recalls involving this device
No recalls on record reference this clearance.