The following data is part of a premarket notification filed by Med-tech Develoment Corp. with the FDA for Diamond Blade Micrometer Knife.
Device ID | K860332 |
510k Number | K860332 |
Device Name: | DIAMOND BLADE MICROMETER KNIFE |
Classification | Knife, Ophthalmic |
Applicant | MED-TECH DEVELOMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
Contact | Jose H Bedoya |
Correspondent | Jose H Bedoya MED-TECH DEVELOMENT CORP. 11300 49TH ST. NORTH Clearwater, FL 33520 |
Product Code | HNN |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-29 |
Decision Date | 1986-02-13 |