The following data is part of a premarket notification filed by Pilling Co. with the FDA for Pentax Lh-150f Light Source.
Device ID | K771739 |
510k Number | K771739 |
Device Name: | PENTAX LH-150F LIGHT SOURCE |
Classification | Light Source, Fiberoptic, Routine |
Applicant | PILLING CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FCW |
CFR Regulation Number | 876.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-09-15 |
Decision Date | 1977-09-30 |