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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K861163
Device Name XTAL X-800 SHADOWGRAPH
Applicant
Xtal Corp.
215 S. Highway 101
Suite 200-A
Solana Beach,  CA  92075
Applicant Contact ALAN P SCHWARTZ
Correspondent
Xtal Corp.
215 S. Highway 101
Suite 200-A
Solana Beach,  CA  92075
Correspondent Contact ALAN P SCHWARTZ
Date Received03/28/1986
Decision Date 05/06/1986
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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