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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K837608
Device Name PIP X-RAY PROTECTIVE GLASSES
Applicant
Pinnacle Intl., Inc.
41 Ralsey Rd. S.
Stamford,  CT  06902
Correspondent
Pinnacle Intl., Inc.
41 Ralsey Rd. S.
Stamford,  CT  06902
Date Received05/16/1983
Decision Date 06/27/1983
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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