The following data is part of a premarket notification filed by Dravon Medical, Inc. with the FDA for Hemostatic/tube Occluding Forceps.
Device ID | K800435 |
510k Number | K800435 |
Device Name: | HEMOSTATIC/TUBE OCCLUDING FORCEPS |
Classification | Forceps, General & Plastic Surgery |
Applicant | DRAVON MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GEN |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-02-27 |
Decision Date | 1980-03-12 |