The following data is part of a premarket notification filed by Innervision, Inc. with the FDA for Innervision Inc. Laparoscopic Hand Instruments.
| Device ID | K940718 |
| 510k Number | K940718 |
| Device Name: | INNERVISION INC. LAPAROSCOPIC HAND INSTRUMENTS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | INNERVISION, INC. 1755 LYNNFIELD RD. SUITE 190 Memphis, TN 38119 |
| Contact | Frank M Lewis |
| Correspondent | Frank M Lewis INNERVISION, INC. 1755 LYNNFIELD RD. SUITE 190 Memphis, TN 38119 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-18 |
| Decision Date | 1994-07-22 |