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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bottle, Blow
510(k) Number K913527
Device Name HYPERFREE
Applicant
Kist Intl.
550 Lisbon St.
Lewiston,  ME  04240
Applicant Contact LEONARD NIHAN
Correspondent
Kist Intl.
550 Lisbon St.
Lewiston,  ME  04240
Correspondent Contact LEONARD NIHAN
Regulation Number868.5220
Classification Product Code
BYO  
Date Received08/08/1991
Decision Date 01/21/1992
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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