The following data is part of a premarket notification filed by Medco Products, Co., Inc. with the FDA for Endoscopic Delivery System.
| Device ID | K913172 |
| 510k Number | K913172 |
| Device Name: | ENDOSCOPIC DELIVERY SYSTEM |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDCO PRODUCTS, CO., INC. 232 WEST CUMMINGS PARK Woburn, MA 01801 |
| Contact | Diane Tiernan |
| Correspondent | Diane Tiernan MEDCO PRODUCTS, CO., INC. 232 WEST CUMMINGS PARK Woburn, MA 01801 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-17 |
| Decision Date | 1991-09-06 |