The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for Inman Medical Oil Emulsion Dressing.
Device ID | K921290 |
510k Number | K921290 |
Device Name: | INMAN MEDICAL OIL EMULSION DRESSING |
Classification | Gauze, External (with Drug/biologic/animal Source Material) |
Applicant | INMAN MEDICAL CORP. 3815 E. LOOP 820 SOUTH Forth Worth, TX 76119 |
Contact | Glenn Crum |
Correspondent | Glenn Crum INMAN MEDICAL CORP. 3815 E. LOOP 820 SOUTH Forth Worth, TX 76119 |
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 | 1992-03-11 |
Decision Date | 1992-11-23 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
50885380052338 | K921290 | 000 |
50885380052307 | K921290 | 000 |
50885380052284 | K921290 | 000 |
20885380052276 | K921290 | 000 |
00888499000936 | K921290 | 000 |
00888499000929 | K921290 | 000 |
40612479198621 | K921290 | 000 |
40612479198591 | K921290 | 000 |