The following data is part of a premarket notification filed by Andrew Surgical with the FDA for Andrew Laparoscopic Surgical Instruments.
| Device ID | K912614 |
| 510k Number | K912614 |
| Device Name: | ANDREW LAPAROSCOPIC SURGICAL INSTRUMENTS |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ANDREW SURGICAL 2405 ANNAPOLIS LANE, SUITE 266 Plymouth, MN 55441 |
| Contact | David H Dulebohn |
| Correspondent | David H Dulebohn ANDREW SURGICAL 2405 ANNAPOLIS LANE, SUITE 266 Plymouth, MN 55441 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-12 |
| Decision Date | 1991-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884524001838 | K912614 | 000 |