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510(k) K913527

HYPERFREE by Kist Intl. — Product Code BYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 1992
Date Received
August 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Blow
Device Class
Class I
Regulation Number
868.5220
Review Panel
AN
Submission Type

Other clearances for product code BYO

  • K924541 — EPIDURAL MINIPACK (July 9, 1993)
  • K780558 — BOTTLE BREATHING DEVICE (May 26, 1978)
  • K780407 — 2C7125 BLOW BOTTLE (April 10, 1978)