VAGINAL ILLUMINATOR, MODEL 78570
FDA 510(k) clearance K771181 · decided 1977-07-14
Clearance details
- K-number
- K771181
- Device name
- VAGINAL ILLUMINATOR, MODEL 78570
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-06-30
- Decision date
- 1977-07-14
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- HDG
- Device class
- 1
- Regulation number
- 884.4520
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|
| SPECULUM, VAGINAL, METAL FIBEROPTIC (K864865) | Luxtec Corp. | 1987-01-09 |
Recalls involving this device
No recalls on record reference this clearance.