The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Laparoscope.
| Device ID | K910132 |
| 510k Number | K910132 |
| Device Name: | STRYKER LAPAROSCOPE |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | STRYKER CORP. P.O. BOX 4085 Kalamazoo, MI 49003 -4085 |
| Contact | Harmon Woodworth |
| Correspondent | Harmon Woodworth STRYKER CORP. P.O. BOX 4085 Kalamazoo, MI 49003 -4085 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-09 |
| Decision Date | 1991-02-21 |