The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Vg 200 Video Gastroscope.
| Device ID | K971734 |
| 510k Number | K971734 |
| Device Name: | VG 200 VIDEO GASTROSCOPE |
| Classification | Gastroscope 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 | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1997-07-29 |