The following data is part of a premarket notification filed by M. Imonti And Associates Inc., with the FDA for Drainage Tube Restraint/wound Cover.
| Device ID | K905766 |
| 510k Number | K905766 |
| Device Name: | DRAINAGE TUBE RESTRAINT/WOUND COVER |
| Classification | Catheter, Irrigation |
| Applicant | M. IMONTI AND ASSOCIATES INC., 25707 COMPASS WAY San Juan Capistrano, CA 92675 |
| Contact | Maurice Imonti |
| Correspondent | Maurice Imonti M. IMONTI AND ASSOCIATES INC., 25707 COMPASS WAY San Juan Capistrano, CA 92675 |
| Product Code | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-27 |
| Decision Date | 1991-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002462905 | K905766 | 000 |
| 10827002462899 | K905766 | 000 |