The following data is part of a premarket notification filed by Medical Device Inspection Co., Inc. with the FDA for Open Heart Tray.
| Device ID | K912053 |
| 510k Number | K912053 |
| Device Name: | OPEN HEART TRAY |
| Classification | Tray, Surgical, Instrument |
| 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 | FSM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-09 |
| Decision Date | 1991-08-26 |