The following data is part of a premarket notification filed by Adrian Anesthesia Systems, Inc. with the FDA for Needlesafe Handguard.
| Device ID | K931813 |
| 510k Number | K931813 |
| Device Name: | NEEDLESAFE HANDGUARD |
| Classification | Set, Administration, Intravascular |
| Applicant | ADRIAN ANESTHESIA SYSTEMS, INC. 3325 S. ADRIAN HIGHWAY Adrian, MI 49221 |
| Contact | Martin Kempen |
| Correspondent | Martin Kempen ADRIAN ANESTHESIA SYSTEMS, INC. 3325 S. ADRIAN HIGHWAY Adrian, MI 49221 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-08 |
| Decision Date | 1993-07-22 |