The following data is part of a premarket notification filed by Innovasive Devices, Inc. with the FDA for Innovasive Non-sterile Laparoscopy Instruments Modification.
| Device ID | K934338 |
| 510k Number | K934338 |
| Device Name: | INNOVASIVE NON-STERILE LAPAROSCOPY INSTRUMENTS MODIFICATION |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton, MA 01748 |
| Contact | Eric Bannon |
| Correspondent | Eric Bannon INNOVASIVE DEVICES, INC. 100B SOUTH ST. Hopkinton, MA 01748 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-07 |
| Decision Date | 1994-02-10 |