The following data is part of a premarket notification filed by Davol, Inc. with the FDA for Laparoscopic Aspiration Probe.
| Device ID | K910340 |
| 510k Number | K910340 |
| Device Name: | LAPAROSCOPIC ASPIRATION PROBE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Contact | Leo L Basta |
| Correspondent | Leo L Basta DAVOL, INC. 100 SOCKANOSSETT CROSSROAD P.O. BOX 8500 Cranston, RI 02920 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-28 |
| Decision Date | 1991-02-26 |