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FDA 510(k) Application Details - K172925
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K172925
Device Name
Case, Contact Lens
Applicant
P L Overseas Limited
Rm. A 4/F Alexandra Indl. Bldg. Blk.A
1064-1066 Tung Chau West St.
Cheung Sha Wan HK
Other 510(k) Applications for this Company
Contact
Maggie Li
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/25/2017
Decision Date
11/30/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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