The following data is part of a premarket notification filed by Laparomed Corp. with the FDA for Laparomed Hook/spatula Device.
| Device ID | K910074 |
| 510k Number | K910074 |
| Device Name: | LAPAROMED HOOK/SPATULA DEVICE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | LAPAROMED CORP. 9272 JERONIMO RD., UNIT 109 Irvine, CA 92718 |
| Contact | Paul Lubock |
| Correspondent | Paul Lubock LAPAROMED CORP. 9272 JERONIMO RD., UNIT 109 Irvine, CA 92718 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-08 |
| Decision Date | 1991-07-02 |