The following data is part of a premarket notification filed by Gainor Medical U.s.a., Inc. with the FDA for Surewing.
| Device ID | K944824 |
| 510k Number | K944824 |
| Device Name: | SUREWING |
| Classification | Set, Administration, Intravascular |
| Applicant | GAINOR MEDICAL U.S.A., INC. 2205 HIGHWAY 42 NORTH P.O. BOX 353 Mcdonough, GA 30253 -0353 |
| Contact | William C Taylor |
| Correspondent | William C Taylor GAINOR MEDICAL U.S.A., INC. 2205 HIGHWAY 42 NORTH P.O. BOX 353 Mcdonough, GA 30253 -0353 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-29 |
| Decision Date | 1995-03-29 |