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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Clinical Color Change
510(k) Number K881286
Device Name TEMPA-DOT CLINICAL THERMOMETER SHEATH
Applicant
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Applicant Contact THOMAS THACKSTON
Correspondent
Pymah Corp.
89 Rte. 206
P.O. Box 1114
Somerville,  NJ  08876
Correspondent Contact THOMAS THACKSTON
Regulation Number880.2900
Classification Product Code
FQZ  
Date Received03/25/1988
Decision Date 06/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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