The following data is part of a premarket notification filed by Armm, Inc. with the FDA for Superflow Irrigation And Aspiration Tubing Sets.
| Device ID | K981286 |
| 510k Number | K981286 |
| Device Name: | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS |
| Classification | Catheter (gastric, Colonic, Etc.), Irrigation And Aspiration |
| Applicant | ARMM, INC. 17744 SAMPSON LN. Huntington Beach, CA 92647 |
| Contact | Roger Wood |
| Correspondent | Roger Wood ARMM, INC. 17744 SAMPSON LN. Huntington Beach, CA 92647 |
| Product Code | KDH |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-08 |
| Decision Date | 1998-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850082007056 | K981286 | 000 |
| 10850082007049 | K981286 | 000 |
| 10850082007032 | K981286 | 000 |
| 00850082007127 | K981286 | 000 |
| 00850082007110 | K981286 | 000 |
| 00850082007103 | K981286 | 000 |