The following data is part of a premarket notification filed by I-tech Industries, Inc. with the FDA for Nsn #6515-00-333-2400 Adson Dressing Forceps.
Device ID | K874634 |
510k Number | K874634 |
Device Name: | NSN #6515-00-333-2400 ADSON DRESSING FORCEPS |
Classification | Forceps, General & Plastic Surgery |
Applicant | I-TECH INDUSTRIES, INC. 849 WESTWOOD AVE. Addison, IL 60101 |
Contact | M Gendrikovs |
Correspondent | M Gendrikovs I-TECH INDUSTRIES, INC. 849 WESTWOOD AVE. Addison, IL 60101 |
Product Code | GEN |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-10 |
Decision Date | 1987-12-02 |