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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K910072
Device Name SURE GRIP, HAND CONTROLS MODEL SG-1
Applicant
Howell Ventures , Ltd.
Rr #6
Fredericton, N.B.,  CA E3B 4X7
Applicant Contact KEITH HOWELL
Correspondent
Howell Ventures , Ltd.
Rr #6
Fredericton, N.B.,  CA E3B 4X7
Correspondent Contact KEITH HOWELL
Classification Product Code
IPQ
Date Received01/09/1991
Decision Date 01/23/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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