510(k) K771181
- Device
- VAGINAL ILLUMINATOR, MODEL 78570
- Applicant
- Welch Allyn, Inc.
- 510(k) number
- K771181
- Product code
- HDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-07-14
- Date received
- 1977-06-30
- Regulation
- 884.4520
- Classification name
- Speculum, Vaginal, Metal, Fiberoptic
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3015143057
- 3006897996
- 3003032798
- 3011371465
- 1315756
- 2020550
- 9680519
- 3011137372
- 9611283
- 3013530901
- 3010202439
- 3009255580
- 3010041511
- 8040278
- 3003431869
- 9614093
- 3032747418
- 3008902714
- 3031564283
- 9613083
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HDG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K864865 | SPECULUM, VAGINAL, METAL FIBEROPTIC | Luxtec Corp. | 1987-01-09 |