The following data is part of a premarket notification filed by Phoenix Instruments Div. with the FDA for Manual Surgical Instruments.
| Device ID | K920263 |
| 510k Number | K920263 |
| Device Name: | MANUAL SURGICAL INSTRUMENTS |
| Classification | Instrument, Surgical, Disposable |
| Applicant | PHOENIX INSTRUMENTS DIV. 1020 FULLERTON AVE. UNIT C Addison, IL 60101 |
| Contact | Sharon L Freedman |
| Correspondent | Sharon L Freedman PHOENIX INSTRUMENTS DIV. 1020 FULLERTON AVE. UNIT C Addison, IL 60101 |
| Product Code | KDC |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-21 |
| Decision Date | 1992-05-06 |