The following data is part of a premarket notification filed by Innervision, Inc. with the FDA for Christoudias Gauze Dissector (laparoscopic Hand Instrument).
| Device ID | K982428 |
| 510k Number | K982428 |
| Device Name: | CHRISTOUDIAS GAUZE DISSECTOR (LAPAROSCOPIC HAND INSTRUMENT) |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | INNERVISION, INC. 6258 SHADY GROVE RD. E. Memphis, TN 38120 |
| Contact | Frank M Lewis |
| Correspondent | Frank M Lewis INNERVISION, INC. 6258 SHADY GROVE RD. E. Memphis, TN 38120 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-13 |
| Decision Date | 1998-10-09 |