The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Micromedics Fibrijet Air Assisted Endoscopic Applicator.
| Device ID | K042834 |
| 510k Number | K042834 |
| Device Name: | MICROMEDICS FIBRIJET AIR ASSISTED ENDOSCOPIC APPLICATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 St Paul, MN 55121 |
| Contact | Thomas A Lopac |
| Correspondent | Thomas A Lopac MICROMEDICS, INC. 1270 EAGAN INDUSTRIAL ROAD SUITE 120 St Paul, MN 55121 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-13 |
| Decision Date | 2005-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815634020283 | K042834 | 000 |
| 10815634021201 | K042834 | 000 |
| 10815634021034 | K042834 | 000 |
| 10815634021041 | K042834 | 000 |
| 10815634021188 | K042834 | 000 |
| 10815634021010 | K042834 | 000 |
| 10815634021027 | K042834 | 000 |
| 20815634020065 | K042834 | 000 |
| 10815634020075 | K042834 | 000 |
| 00815634020085 | K042834 | 000 |
| 20815634020164 | K042834 | 000 |
| 00815634020177 | K042834 | 000 |
| 00815634020184 | K042834 | 000 |
| 00815634020191 | K042834 | 000 |
| 00815634020276 | K042834 | 000 |
| 10815634021065 | K042834 | 000 |