The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Vs-100 Video Sigmoidoscope.
| Device ID | K970382 |
| 510k Number | K970382 |
| Device Name: | VS-100 VIDEO SIGMOIDOSCOPE |
| Classification | Sigmoidoscope And Accessories, Flexible/rigid |
| Applicant | WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Contact | Lawrence E Marocco |
| Correspondent | Lawrence E Marocco WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 Skaneateles Falls, NY 13153 -0220 |
| Product Code | FAM |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-03 |
| Decision Date | 1997-04-17 |