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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K834539
Device Name AXIPAC II
Applicant
Teknar, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Teknar, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Date Received12/14/1983
Decision Date 09/11/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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