The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for Compound Benzoin Tincture Usp Frepp.
| Device ID | K920399 |
| 510k Number | K920399 |
| Device Name: | COMPOUND BENZOIN TINCTURE USP FREPP |
| Classification | Bandage, Liquid |
| Applicant | MEDI-FLEX HOSPITAL PRODUCTS, INC. 8717 W. 110TH ST., SUITE 750 Overland Park, KS 66210 -2103 |
| Contact | Orlando Cordova |
| Correspondent | Orlando Cordova MEDI-FLEX HOSPITAL PRODUCTS, INC. 8717 W. 110TH ST., SUITE 750 Overland Park, KS 66210 -2103 |
| Product Code | KMF |
| CFR Regulation Number | 880.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-30 |
| Decision Date | 1994-01-25 |