The following data is part of a premarket notification filed by Surgimark, Inc. with the FDA for Lapro-loader(tm).
| Device ID | K932689 |
| 510k Number | K932689 |
| Device Name: | LAPRO-LOADER(TM) |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | SURGIMARK, INC. 4706 WEST NOB HILL BLVD. Yakima, WA 98908 |
| Contact | Richard Yarger |
| Correspondent | Richard Yarger SURGIMARK, INC. 4706 WEST NOB HILL BLVD. Yakima, WA 98908 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-03 |
| Decision Date | 1994-04-11 |