The following data is part of a premarket notification filed by Micromedics, Inc. with the FDA for Malleable Tip Endoscopic Applicator.
| Device ID | K123847 |
| 510k Number | K123847 |
| Device Name: | MALLEABLE TIP ENDOSCOPIC APPLICATOR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MICROMEDICS, INC. 1270 Eagan Industrial Rd Ste 120 Saint Paul, MN 55121 |
| Contact | Jodi L Raus |
| Correspondent | Jodi L Raus MICROMEDICS, INC. 1270 Eagan Industrial Rd Ste 120 Saint Paul, MN 55121 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-14 |
| Decision Date | 2013-01-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815634020313 | K123847 | 000 |