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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K842670
Device Name BIOLAS YAG 100
Applicant
Advanced Biomedical Instruments
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Advanced Biomedical Instruments
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received07/10/1984
Decision Date 08/08/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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