The following data is part of a premarket notification filed by Siegel,mandell & Davidson,p.c. with the FDA for Power Rangers Sunglasses.
Device ID | K951008 |
510k Number | K951008 |
Device Name: | POWER RANGERS SUNGLASSES |
Classification | Sunglasses (non-prescription Including Photosensitive) |
Applicant | SIEGEL,MANDELL & DAVIDSON,P.C. 1515 BROADWAY 43RD FLOOR New York, NY 10036 -8901 |
Contact | David A Eisen |
Correspondent | David A Eisen SIEGEL,MANDELL & DAVIDSON,P.C. 1515 BROADWAY 43RD FLOOR New York, NY 10036 -8901 |
Product Code | HQY |
CFR Regulation Number | 886.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-06 |
Decision Date | 1995-05-02 |