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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Microscope, Operating & Accessories, Ac-Powered, Ophthalmic
510(k) Number K853855
Device Name XTAL X-150 OPERATING MICROSCOPE
Applicant
Xtal Corp.
215 S. Hwy. 101
Suite 200-A
Solana Beach,  CA  92075
Applicant Contact ALAN P SCHWARTZ
Correspondent
Xtal Corp.
215 S. Hwy. 101
Suite 200-A
Solana Beach,  CA  92075
Correspondent Contact ALAN P SCHWARTZ
Regulation Number878.4700
Classification Product Code
HRM  
Date Received09/16/1985
Decision Date 10/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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