The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Lachrymal Probes-various.
Device ID | K841002 |
510k Number | K841002 |
Device Name: | LACHRYMAL PROBES-VARIOUS |
Classification | Dilator, Lachrymal |
Applicant | PREMIER DENTAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | HNW |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-09 |
Decision Date | 1984-05-09 |