ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
FDA 510(k) clearance K822711 · decided 1982-11-03
Clearance details
- K-number
- K822711
- Device name
- ANTI-MIST, ANTI-FOG EYEGLASS & DENTAL
- Applicant
- Parker Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-07
- Decision date
- 1982-11-03
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- FAX
- Device class
- 1
- Regulation number
- 876.5520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, 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 |
|---|---|---|
| KARL STORZ BOUGIES AND DILATORS (K950125) | KARL STORZ Endoscopy-America, Inc. | 1995-02-07 |
Recalls involving this device
No recalls on record reference this clearance.