The following data is part of a premarket notification filed by O.r. Specialties, Inc. with the FDA for Laparoscopic Scissors (disposable).
| Device ID | K942607 |
| 510k Number | K942607 |
| Device Name: | LAPAROSCOPIC SCISSORS (DISPOSABLE) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | O.R. SPECIALTIES, INC. 4749 APPLETREE LN. Tuscaloosa, AL 35405 |
| Contact | Jack W Howard |
| Correspondent | Jack W Howard O.R. SPECIALTIES, INC. 4749 APPLETREE LN. Tuscaloosa, AL 35405 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-01 |
| Decision Date | 1994-07-06 |