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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K851864
Device Name SPINAL STABILIZING UNIT
Applicant
Counterstress Products, Inc.
7520 El Cajon Blvd. 105
La Mesa,  CA  92041
Applicant Contact GREGORY MELVIN
Correspondent
Counterstress Products, Inc.
7520 El Cajon Blvd. 105
La Mesa,  CA  92041
Correspondent Contact GREGORY MELVIN
Date Received04/26/1985
Decision Date 12/16/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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