The following data is part of a premarket notification filed by Gerard Medical, Inc. with the FDA for Endo-needle Instrument.
| Device ID | K936207 |
| 510k Number | K936207 |
| Device Name: | ENDO-NEEDLE INSTRUMENT |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | GERARD MEDICAL, INC. 90 WORCESTER RD. Charlton, MA 01507 |
| Contact | Richard Cayer, Jr. |
| Correspondent | Richard Cayer, Jr. GERARD MEDICAL, INC. 90 WORCESTER RD. Charlton, MA 01507 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-06-16 |