The following data is part of a premarket notification filed by F.m. Wiest Usa, Inc. with the FDA for Laparoflator 3000, Standard And Electronic.
| Device ID | K875137 |
| 510k Number | K875137 |
| Device Name: | LAPAROFLATOR 3000, STANDARD AND ELECTRONIC |
| Classification | Insufflator, Carbon-dioxide, Uterotubal (and Accessories) |
| Applicant | F.M. WIEST USA, INC. 1301 N. KINGS HIGHWAY Cherry Hill, NJ 08034 |
| Contact | Wayne W Disanza |
| Correspondent | Wayne W Disanza F.M. WIEST USA, INC. 1301 N. KINGS HIGHWAY Cherry Hill, NJ 08034 |
| Product Code | HES |
| CFR Regulation Number | 884.1300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-15 |
| Decision Date | 1988-03-02 |