The following data is part of a premarket notification filed by W.o.m. Gmhb with the FDA for Surgiflator-40.
| Device ID | K001533 |
| 510k Number | K001533 |
| Device Name: | SURGIFLATOR-40 |
| Classification | Insufflator, Laparoscopic |
| Applicant | W.O.M. GMHB 194 BRANCH ST. Mansfield, MA 02048 |
| Contact | Michael Mcgrail |
| Correspondent | Michael Mcgrail W.O.M. GMHB 194 BRANCH ST. Mansfield, MA 02048 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-17 |
| Decision Date | 2000-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056702000080 | K001533 | 000 |