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510(k) K893939

ISOLATION MASKS by James River Corp. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1989
Date Received
May 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Surgical
Device Class
Class II
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by James River Corp.

  • K894505 — COTOLIN DRAIN SPONGE AND DRESSING SPONGE (September 15, 1989)
  • K894147 — VISULIN TRANSPARENT ADHESIVE DRESSING (August 9, 1989)
  • K892580 — CARETOUCH EXAMINATION GLOVES (July 14, 1989)
  • K894034 — MODIFIED LABELING OF SURGICAL GLOVES (July 14, 1989)
  • K890459 — JAMES RIVER BIOGEL POWDERLESS SURGICAL GLOVES (April 20, 1989)
  • K883802 — CARETEX CENTRAL SUPPLY WRAP (October 21, 1988)
  • K884112 — CARETEX OR TOWEL (October 13, 1988)
  • K883657 — SKID RESISTANT, LONG LASTING SHOE COVERS (September 15, 1988)
  • K880481 — CARETEX SURGEON'S CAPS (February 24, 1988)
  • K880431 — CARETEX SURGEON'S HOODS (February 24, 1988)

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