The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Dorc Corneal Punch Block.
Device ID | K830335 |
510k Number | K830335 |
Device Name: | DORC CORNEAL PUNCH BLOCK |
Classification | Punch, Corneo-scleral |
Applicant | JEDMED INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HNJ |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-02-01 |
Decision Date | 1983-03-09 |