The following data is part of a premarket notification filed by Enterprise Medical Corp. with the FDA for Laporoscopic Scissors.
| Device ID | K942431 |
| 510k Number | K942431 |
| Device Name: | LAPOROSCOPIC SCISSORS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ENTERPRISE MEDICAL CORP. 3214 BRASSFIELD RD., #2201 Greensboro, NC 27410 |
| Contact | Reuben Margoliash |
| Correspondent | Reuben Margoliash ENTERPRISE MEDICAL CORP. 3214 BRASSFIELD RD., #2201 Greensboro, NC 27410 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-20 |
| Decision Date | 1995-10-11 |