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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K884157
Device Name MODIFIED TOUCH-ME-NOT MASK
Applicant
Walt'S Products
1001 S. Marshall St.
Suite 18
Winston-Salem,  NC  27101
Applicant Contact WALT SWINTON
Correspondent
Walt'S Products
1001 S. Marshall St.
Suite 18
Winston-Salem,  NC  27101
Correspondent Contact WALT SWINTON
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received10/04/1988
Decision Date 08/21/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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