The following data is part of a premarket notification filed by Disposable Sterile Surgical Instruments, Inc. with the FDA for Surgical Instruments (various Types & Sizes).
| Device ID | K884196 |
| 510k Number | K884196 |
| Device Name: | SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES) |
| Classification | Hemostat |
| Applicant | DISPOSABLE STERILE SURGICAL INSTRUMENTS, INC. 35 FAIRLEA DR. Rochester, NY 14622 |
| Contact | Leon R Cuff |
| Correspondent | Leon R Cuff DISPOSABLE STERILE SURGICAL INSTRUMENTS, INC. 35 FAIRLEA DR. Rochester, NY 14622 |
| Product Code | HRQ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-04 |
| Decision Date | 1988-11-08 |