The following data is part of a premarket notification filed by New England Surgical Instrument Corp. with the FDA for Rowe Shoulder Instr. For Bankhart Repair.
| Device ID | K820344 |
| 510k Number | K820344 |
| Device Name: | ROWE SHOULDER INSTR. FOR BANKHART REPAIR |
| Classification | Forceps |
| Applicant | NEW ENGLAND SURGICAL INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HTD |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-08 |
| Decision Date | 1982-03-08 |