The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Single Cannula Extended Applicator.
| Device ID | K102563 |
| 510k Number | K102563 |
| Device Name: | SINGLE CANNULA EXTENDED APPLICATOR |
| Classification | Syringe, Irrigating (non Dental) |
| Applicant | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD St Paul, MN 55121 -1385 |
| Contact | Tom Lopac |
| Correspondent | Tom Lopac MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD St Paul, MN 55121 -1385 |
| Product Code | KYZ |
| CFR Regulation Number | 880.6960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-07 |
| Decision Date | 2011-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815634020214 | K102563 | 000 |
| 00815634020207 | K102563 | 000 |