The following data is part of a premarket notification filed by Armm, Inc. with the FDA for Meddrains.
| Device ID | K931607 |
| 510k Number | K931607 |
| Device Name: | MEDDRAINS |
| Classification | Catheter, Pediatric, General & Plastic Surgery |
| Applicant | ARMM, INC. 17744 SAMPSON LN. Huntington Beach, CA 92647 |
| Contact | Michael E Hamlin |
| Correspondent | Michael E Hamlin ARMM, INC. 17744 SAMPSON LN. Huntington Beach, CA 92647 |
| Product Code | GBN |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-01 |
| Decision Date | 1993-08-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850082007981 | K931607 | 000 |
| 00850082007974 | K931607 | 000 |
| 00850005416067 | K931607 | 000 |
| 00850005416050 | K931607 | 000 |
| 00850005416029 | K931607 | 000 |