The following data is part of a premarket notification filed by Armm, Inc. with the FDA for Endosi Suction Irrigator.
| Device ID | K923201 |
| 510k Number | K923201 |
| Device Name: | ENDOSI SUCTION IRRIGATOR |
| Classification | Laparoscope, 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 | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-30 |
| Decision Date | 1993-09-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10850082007063 | K923201 | 000 |
| 10850082007025 | K923201 | 000 |
| 10850082007018 | K923201 | 000 |