The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Major Set-up Tray.
| Device ID | K912159 |
| 510k Number | K912159 |
| Device Name: | MAJOR SET-UP TRAY |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Contact | Alan P Schwartz |
| Correspondent | Alan P Schwartz MEDICAL DEVICE INSPECTION CO., INC. 55 NORTHERN BLVD. SUITE 301 Great Neck, NY 11021 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-16 |
| Decision Date | 1991-08-29 |