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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorber, Carbon-Dioxide
510(k) Number K834535
Device Name NITROUS OXIDE RECYCLER
Applicant
G & L UNLTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
G & L UNLTD.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5310
Classification Product Code
BSF  
Date Received12/22/1983
Decision Date 06/07/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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