The following data is part of a premarket notification filed by Lap Associates Of Nashville, Ii, Inc. with the FDA for Canuseal.
| Device ID | K925932 |
| 510k Number | K925932 |
| Device Name: | CANUSEAL |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | LAP ASSOCIATES OF NASHVILLE, II, INC. 19531 N.E. 18TH COURT Miami, FL 33179 |
| Contact | Frank Goldfarb |
| Correspondent | Frank Goldfarb LAP ASSOCIATES OF NASHVILLE, II, INC. 19531 N.E. 18TH COURT Miami, FL 33179 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-23 |
| Decision Date | 1993-04-23 |