510(k) K900523

MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP. by J & B Assoc. — Product Code HQY

K900523 is an FDA 510(k) premarket notification submitted by J & B Assoc. for the device "MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP.". The FDA issued a decision of Substantially Equivalent on February 27, 1990. The device falls under product code HQY (Sunglasses (Non-Prescription Including Photosensitive)), a Class I device regulated under 21 CFR 886.5850. J & B Assoc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1990
Date Received
February 2, 1990
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