The following data is part of a premarket notification filed by F.m. Wiest Usa, Inc. with the FDA for Laparoflator Electronic 3509.
| Device ID | K910883 |
| 510k Number | K910883 |
| Device Name: | LAPAROFLATOR ELECTRONIC 3509 |
| Classification | Insufflator, Laparoscopic |
| Applicant | F.M. WIEST USA, INC. P.O. BOX 637 Oradel, NJ 07649 |
| Contact | George R Batchelor |
| Correspondent | George R Batchelor F.M. WIEST USA, INC. P.O. BOX 637 Oradel, NJ 07649 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-03-29 |