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FDA 510(k) Application Details - K981196
Device Classification Name
Laser, Ophthalmic
More FDA Info for this Device
510(K) Number
K981196
Device Name
Laser, Ophthalmic
Applicant
AESCULAP-MEDITEC NORTH AMERICA
23832 VIA MONTE
COTO DE CAZA, CA 92679-4001 US
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Contact
WILLIAM T KELLEY
Other 510(k) Applications for this Contact
Regulation Number
886.4390
More FDA Info for this Regulation Number
Classification Product Code
HQF
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More FDA Info for this Product Code
Date Received
03/19/1998
Decision Date
06/17/1998
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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