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510(k) K012277

PORTEX RING PESSARY PVC-NON STERILE; PORTEX RING PESSARY POLYTHENE- NON STERILE by Sims Portex , Ltd. — Product Code HHW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2002
Date Received
July 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pessary, Vaginal
Device Class
Class II
Regulation Number
884.3575
Review Panel
OB
Submission Type

Other clearances by Sims Portex , Ltd.

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  • K002201 — ELECTROSTATIC HYDROPHOBIC BREATHING FILTER (February 5, 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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