FDA 510(k) Application Details - K990224

Device Classification Name Weights, Eyelid, External

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510(K) Number K990224
Device Name Weights, Eyelid, External
Applicant LABTICIAN OPHTHALMICS, INC.
2140 WINSTON PARK DR., UNIT 6
OAKVILLE, ONTARIO L6H 5V5 CA
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Contact R. DAVID SCULATI
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Regulation Number 000.0000

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Classification Product Code MML
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Date Received 01/25/1999
Decision Date 04/12/1999
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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