The following data is part of a premarket notification filed by Intramed Laboratories, Inc. with the FDA for Laparoscope.
| Device ID | K903528 |
| 510k Number | K903528 |
| Device Name: | LAPAROSCOPE |
| Classification | Laparoscope, Gynecologic (and Accessories) |
| Applicant | INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Contact | Stephen A Sosnowski |
| Correspondent | Stephen A Sosnowski INTRAMED LABORATORIES, INC. 11100 ROSELLE ST. San Diego, CA 92121 |
| Product Code | HET |
| CFR Regulation Number | 884.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-06 |
| Decision Date | 1990-09-04 |