The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for Inman Medical Petrolatum Dressing.
Device ID | K921289 |
510k Number | K921289 |
Device Name: | INMAN MEDICAL PETROLATUM 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 Grum |
Correspondent | Glenn Grum 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 (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-11 |
Decision Date | 1992-11-10 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20885380052245 | K921289 | 000 |
50885380052239 | K921289 | 000 |
50885380052222 | K921289 | 000 |