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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Operating, Dental
510(k) Number K884223
Device Name DENTAL LAMP HANDLE COVER
Applicant
Steri-Shield Products, Inc.
3620 Hamilton Blvd.
Allentown,  PA  18103
Applicant Contact MARK EISNER
Correspondent
Steri-Shield Products, Inc.
3620 Hamilton Blvd.
Allentown,  PA  18103
Correspondent Contact MARK EISNER
Regulation Number872.4630
Classification Product Code
EAZ  
Date Received10/06/1988
Decision Date 03/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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