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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K827913
Device Name NIIC CO2 LASER SYSTEM MODEL 6OZ.
Applicant
Cooper Lasersonics, Inc.
40 Ramland Rd.
Orangeburg,  NY  10962
Correspondent
Cooper Lasersonics, Inc.
40 Ramland Rd.
Orangeburg,  NY  10962
Date Received08/13/1982
Decision Date 09/13/1982
Decision Substantially Equivalent (SESE)
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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