The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Surgical Sealant Applicator Tip Endoscopic Tip.
| Device ID | K940371 |
| 510k Number | K940371 |
| Device Name: | SURGICAL SEALANT APPLICATOR TIP ENDOSCOPIC TIP |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | MICROMEDICS, INC. 1285 CORPORATE CENTER DR., #150 Eagan, MN 55121 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-06 |
| Decision Date | 1994-04-06 |