FDA 510(k) Substantially Equivalent 🇺🇸 United States

POLYCORE

K Number: K832461 · Decision Aug 16, 1983
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
21

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Basic Information

Device Name
POLYCORE
K Number
K832461
Clearance Type
Traditional
Decision
Substantially Equivalent
Applicant
Polycore Optical Pte , Ltd.
Date Received
July 26, 1983
Decision Date
August 16, 1983
Advisory Committee
Unknown
Review Advisory Committee
OP
Third Party
N

Other Clearances by Polycore Optical Pte , Ltd.

K Number Device Name
K822542 POLYCORE
K822430 KRYPTOX-ROUND SEGMENT BIFOCAL
K822429 SINGLE VISION POWER LENS
K822431 SUNGLASS & SAFETY PLANO LENS
K822541 VISIOPAL 75
K790215 LENS, POLYCORE