The following data is part of a premarket notification filed by Medgyn Products, Inc. with the FDA for Al-106, Al-106sa And Al-106b Medgyn Digital Video Colposcope.
| Device ID | K122973 |
| 510k Number | K122973 |
| Device Name: | AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE |
| Classification | Colposcope (and Colpomicroscope) |
| Applicant | MEDGYN PRODUCTS, INC. 12 SOUTH FIRST STREE 12TH FLOOR San Jose, CA 95113 |
| Contact | Stephanie Blair |
| Correspondent | Stephanie Blair MEDGYN PRODUCTS, INC. 12 SOUTH FIRST STREE 12TH FLOOR San Jose, CA 95113 |
| Product Code | HEX |
| CFR Regulation Number | 884.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-26 |
| Decision Date | 2013-06-12 |
| Summary: | summary |