FDA 510(k) Application Details - K172925

Device Classification Name Case, Contact Lens

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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
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Contact Maggie Li
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Regulation Number 886.5928

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Classification Product Code LRX
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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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