The following data is part of a premarket notification filed by Imtec Corp. with the FDA for Laparoscopy Sets, Needle Holders, Blunt Shears.
| Device ID | K923259 |
| 510k Number | K923259 |
| Device Name: | LAPAROSCOPY SETS, NEEDLE HOLDERS, BLUNT SHEARS |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | IMTEC CORP. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
| Contact | Mark C Hamblin |
| Correspondent | Mark C Hamblin IMTEC CORP. 3071 CONTINENTAL DR. West Palm Beach, FL 33407 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-02 |
| Decision Date | 1994-04-11 |