The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Umi Disposable Butterfly Style Puncture Needle.
| Device ID | K881796 |
| 510k Number | K881796 |
| Device Name: | UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Contact | Charles Copperberg |
| Correspondent | Charles Copperberg UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-27 |
| Decision Date | 1988-07-26 |