The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Crawford Lacrimal Intubation Set.
Device ID | K800089 |
510k Number | K800089 |
Device Name: | CRAWFORD LACRIMAL INTUBATION SET |
Classification | Probe, Lachrymal |
Applicant | JEDMED INSTRUMENT CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HNL |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-14 |
Decision Date | 1980-03-03 |