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510(k) K834454

PAEDIATRIC FACE MASK 1-3 W/WO RING by Warne Surgical Products, Ltd. — Product Code BSJ

K834454 is an FDA 510(k) premarket notification submitted by Warne Surgical Products, Ltd. for the device "PAEDIATRIC FACE MASK 1-3 W/WO RING". The FDA issued a decision of Substantially Equivalent on January 18, 1984. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Warne Surgical Products, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 18, 1984
Date Received
December 19, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Gas, Anesthetic
Device Class
Class I
Regulation Number
868.5550
Review Panel
AN
Submission Type

Other clearances by Warne Surgical Products, Ltd.

  • K850696 — WSP CODE 4300 DIOMASTER DIAGNOSTIC (May 17, 1985)
  • K850694 — WSP CODE 4310 STRESSCATH (May 17, 1985)
  • K850695 — WSP CODE 4301 DIOMASTER THERAPEUTIC (May 16, 1985)
  • K850693 — WSP CODE 4315 PADTEST (May 10, 1985)
  • K841511 — HAEMATURIA CATHETERS (July 12, 1984)
  • K840687 — KIDNEY TRANSPLANT CATHETER (June 7, 1984)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)
  • K841409 — BUSH NECK W/PLUG (April 18, 1984)
  • K841410 — BUSH NECK W/TAP (April 18, 1984)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • K953107 — ANESTHESIA/RESPIRATORY FACE MASK (August 15, 1995)
  • K953295 — ANESTHESIA FACE MASK (August 11, 1995)
  • K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (July 11, 1995)
  • K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (June 7, 1995)
  • K950771 — DISPOSABLE ADHESIVE FACE MASK (March 10, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)

FDA data resources