The following data is part of a premarket notification filed by Genzyme Surgical Product (genzyme Biosurgery) with the FDA for Endoscopic Camera.
| Device ID | K991416 |
| 510k Number | K991416 |
| Device Name: | ENDOSCOPIC CAMERA |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Mary Mcnamara Cullinane |
| Correspondent | Mary Mcnamara Cullinane GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY) 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-23 |
| Decision Date | 1999-07-20 |
| Summary: | summary |