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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stains, Microbiologic
510(k) Number K881512
Device Name WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY
Applicant
Wescor, Inc.
459 S. Main
Logan,  UT  84321
Applicant Contact WAYNE K BARLOW
Correspondent
Wescor, Inc.
459 S. Main
Logan,  UT  84321
Correspondent Contact WAYNE K BARLOW
Regulation Number864.1850
Classification Product Code
JTS  
Date Received04/11/1988
Decision Date 04/18/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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