510(k) K951008

POWER RANGERS SUNGLASSES by Siegel,Mandell & Davidson,P.C. — Product Code HQY

K951008 is an FDA 510(k) premarket notification submitted by Siegel,Mandell & Davidson,P.C. for the device "POWER RANGERS SUNGLASSES". The FDA issued a decision of Substantially Equivalent on May 2, 1995. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. Siegel,Mandell & Davidson,P.C. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1995
Date Received
March 6, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Device Class
Class I
Regulation Number
886.5850
Review Panel
OP
Submission Type