The following data is part of a premarket notification filed by Medmark, Inc. with the FDA for #157 Exam Light.
Device ID | K893949 |
510k Number | K893949 |
Device Name: | #157 EXAM LIGHT |
Classification | Saw, Pneumatically Powered |
Applicant | MEDMARK, INC. Versailles, OH 45380 |
Contact | John Oldiges |
Correspondent | John Oldiges MEDMARK, INC. Versailles, OH 45380 |
Product Code | KFK |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-06-01 |
Decision Date | 1989-08-07 |