The following data is part of a premarket notification filed by Bull Frog Mfg. Co. with the FDA for Uni-syringe, Uni-tip And Access Syringe Tips.
| Device ID | K942519 |
| 510k Number | K942519 |
| Device Name: | UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS |
| Classification | Unit, Syringe, Air And/or Water |
| Applicant | BULL FROG MFG. CO. 5304 N. ALBINA Portland, OR 97217 |
| Contact | Charles W Hutchins |
| Correspondent | Charles W Hutchins BULL FROG MFG. CO. 5304 N. ALBINA Portland, OR 97217 |
| Product Code | ECB |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-26 |
| Decision Date | 1994-08-23 |