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510(k) K002201

ELECTROSTATIC HYDROPHOBIC BREATHING FILTER by Sims Portex, Inc. — Product Code CAH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2001
Date Received
July 20, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Bacterial, Breathing-Circuit
Device Class
Class II
Regulation Number
868.5260
Review Panel
HO
Submission Type

Other clearances by Sims Portex, Inc.

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  • K011925 — HYPODERMIC NEEDLE-PRO NEEDLE WITH NEEDLE PROTECTION DEVICE; HYPODERMIC NEEDLE-PR (July 12, 2001)
  • K002506 — BREATHING FILTER FOR DISPOSABLE ANESTHESIA BREATHING CIRCUIT (December 14, 2000)
  • K001555 — SURESAMPLE-WALLACE ENDOMETRIAL SAMPLER, ENDO 26 (August 2, 2000)
  • K001318 — CPAP SYSTEM, MODEL 102001 (July 20, 2000)
  • K993619 — CSECURE COMBINED SPINAL/EPIDURAL ANESTHESIA SYSTEM WITH LOCK (April 28, 2000)
  • K000628 — WALLACE OOCYTE RETRIEVAL SET-16G, MODEL MEONS1633; WALLACE OOCYTE RETRIEVAL SET- (March 13, 2000)
  • K994275 — SIMS PORTEX ANESTHESIA CATHETER (February 22, 2000)
  • K991861 — 1ST RESPONSE INFANT MANUAL RESUSCITATOR, BAG RESEVOIR, 1ST RESPONSE PEDIATRIC MA (January 18, 2000)

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