The following data is part of a premarket notification filed by Aspen Laboratories, Inc. with the FDA for Fiber Optic Adapter #60-0896.
Device ID | K802775 |
510k Number | K802775 |
Device Name: | FIBER OPTIC ADAPTER #60-0896 |
Classification | Source, Carrier, Fiberoptic Light |
Applicant | ASPEN LABORATORIES, INC. MD |
Product Code | EQH |
CFR Regulation Number | 874.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-03 |
Decision Date | 1980-12-16 |