The following data is part of a premarket notification filed by I-tech Industries, Inc. with the FDA for Nsn #6515-00-690-3209 Debakey Tissue Forceps.
| Device ID | K875319 |
| 510k Number | K875319 |
| Device Name: | NSN #6515-00-690-3209 DEBAKEY TISSUE 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 | 1987-12-29 |
| Decision Date | 1988-01-22 |