The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for Imc Saline Wet Dressing.
Device ID | K933774 |
510k Number | K933774 |
Device Name: | IMC SALINE WET DRESSING |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
Contact | John Mayall |
Correspondent | John Mayall INMAN MEDICAL CORP. 6316 AIRPORT FREEWAY Fort Worth, TX 76117 |
Product Code | GER |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-03 |
Decision Date | 1993-11-08 |