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510(k) K880923

PATIENT VENTILATOR ISOLATOR by Dryden Corp. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1988
Date Received
March 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Dryden Corp.

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  • K873927 — REUSEABLE BREATHING TUBES (October 20, 1987)
  • K870859 — BAG-TAIL BLEED VALVE (August 3, 1987)
  • K871386 — BREATHING CIRCUIT (May 29, 1987)
  • K870858 — BADGWELL SAMPLING CATHETER (May 14, 1987)
  • K861540 — DISPOSABLE BERMAN AND GUEDEL AIRWAYS (May 2, 1986)
  • K850644 — NASOPHARYNGEAL AIRWAY-ROBERTAZZI (March 21, 1985)
  • K842843 — DRYDEN SCAVENGER INTERFACE SYSTEM (July 27, 1984)

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