The following data is part of a premarket notification filed by Axiom Medical, Inc. with the FDA for Flat Closed Wound Drain With Trocar.
| Device ID | K965146 |
| 510k Number | K965146 |
| Device Name: | FLAT CLOSED WOUND DRAIN WITH TROCAR |
| Classification | Catheter, Irrigation |
| Applicant | AXIOM MEDICAL, INC. 555 WEST VICTORIA ST. Rancho Dominguez, CA 90220 |
| Contact | Ridwan Hardy |
| Correspondent | Ridwan Hardy AXIOM MEDICAL, INC. 555 WEST VICTORIA ST. Rancho Dominguez, CA 90220 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-23 |
| Decision Date | 1997-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M6652073 | K965146 | 000 |
| M6652233 | K965146 | 000 |
| M6652223 | K965146 | 000 |
| M6652153 | K965146 | 000 |
| M6652143 | K965146 | 000 |
| M6652133 | K965146 | 000 |
| M6652123 | K965146 | 000 |
| M6652063 | K965146 | 000 |
| M6652041 | K965146 | 000 |
| M665203MAT1 | K965146 | 000 |
| M665203AT3 | K965146 | 000 |
| M6652033 | K965146 | 000 |
| M665202AT3 | K965146 | 000 |
| M6652023 | K965146 | 000 |
| M665201AT3 | K965146 | 000 |
| M6652013 | K965146 | 000 |
| M665200MAT1 | K965146 | 000 |
| M665200AT3 | K965146 | 000 |
| M6652243 | K965146 | 000 |
| M6652253 | K965146 | 000 |
| M665803645AT3 | K965146 | 000 |
| M6658036453 | K965146 | 000 |
| M665803643AT3 | K965146 | 000 |
| M6658036433 | K965146 | 000 |
| M665803642AT3 | K965146 | 000 |
| M6658036423 | K965146 | 000 |
| M665803641AT3 | K965146 | 000 |
| M6658036413 | K965146 | 000 |
| M665803640AT3 | K965146 | 000 |
| M6658036403 | K965146 | 000 |
| M665803631AT3 | K965146 | 000 |
| M6658036313 | K965146 | 000 |
| M665803626AT3 | K965146 | 000 |
| M6658036263 | K965146 | 000 |
| M665803621AT3 | K965146 | 000 |
| M6658036213 | K965146 | 000 |
| M665800410AT3 | K965146 | 000 |
| M6652003 | K965146 | 000 |