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510(k) K881648

TRANSFER CONTAINER HUMIDIFIER by Newport Biosystems, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1988
Date Received
April 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Newport Biosystems, Inc.

  • K860282 — RPMI 1640 W/GLUTAMINE W/HEPES (February 5, 1986)
  • K855085 — TISSUE CULTURE MEDIA (January 13, 1986)
  • K853441 — FETAL BOVINE SERUM IN TRANSFER CONTAINER (August 26, 1985)

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