The following data is part of a premarket notification filed by Endo Technic Corp. with the FDA for Laparoscopic Irrigation/aspiration Handpiece.
| Device ID | K930756 |
| 510k Number | K930756 |
| Device Name: | LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | ENDO TECHNIC CORP. 430 10TH ST. ATDC S-206 Atlanta, GA 30318 |
| Contact | Tim B Lusby |
| Correspondent | Tim B Lusby ENDO TECHNIC CORP. 430 10TH ST. ATDC S-206 Atlanta, GA 30318 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-12 |
| Decision Date | 1994-03-09 |