The following data is part of a premarket notification filed by Sims Surgical, Inc. with the FDA for New Length Sugita Appliers.
| Device ID | K902516 |
| 510k Number | K902516 |
| Device Name: | NEW LENGTH SUGITA APPLIERS |
| Classification | Speculum, Vaginal, Nonmetal, Fiberoptic |
| Applicant | SIMS SURGICAL, INC. 15 KIT ST. P.O. BOX 724 Keene, NH 03431 |
| Contact | John D Forster |
| Correspondent | John D Forster SIMS SURGICAL, INC. 15 KIT ST. P.O. BOX 724 Keene, NH 03431 |
| Product Code | HIC |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-07 |
| Decision Date | 1990-07-03 |