The following data is part of a premarket notification filed by Excel Medical, Inc. with the FDA for Syringe Adaptor.
| Device ID | K923966 |
| 510k Number | K923966 |
| Device Name: | SYRINGE ADAPTOR |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | EXCEL MEDICAL, INC. P.O. BOX 1353 Asbury Park, NJ 07712 |
| Contact | Margaret Lumia |
| Correspondent | Margaret Lumia EXCEL MEDICAL, INC. P.O. BOX 1353 Asbury Park, NJ 07712 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-07 |
| Decision Date | 1993-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709080314 | K923966 | 000 |