The following data is part of a premarket notification filed by Medisys Technologies, Inc. with the FDA for Covertip Safety Syringe.
| Device ID | K971077 |
| 510k Number | K971077 |
| Device Name: | COVERTIP SAFETY SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | MEDISYS TECHNOLOGIES, INC. 11605 HITCHING POST LN. Rockville, MD 20852 |
| Contact | Joel S Faden |
| Correspondent | Joel S Faden MEDISYS TECHNOLOGIES, INC. 11605 HITCHING POST LN. Rockville, MD 20852 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1998-05-15 |
| Summary: | summary |