The following data is part of a premarket notification filed by Inman Medical Corp. with the FDA for Inman Medical Packing Strip.
Device ID | K921291 |
510k Number | K921291 |
Device Name: | INMAN MEDICAL PACKING STRIP |
Classification | Anoscope And Accessories |
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 | FER |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-11 |
Decision Date | 1993-01-21 |