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510(k) K893417

SURGIFRESH SUB-MICRON MASK NO. 901008-000 by Texas Medical Products, Inc. — Product Code FXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
May 2, 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 Texas Medical Products, Inc.

  • K870932 — SURGIFRESH SURGICAL SMOKE REMOVAL (March 31, 1987)
  • K851575 — DR. BRUNO LNAGE MINI PHOTOMETER (October 18, 1985)
  • K830634 — CARDIOTOMY FILTER (June 30, 1983)
  • K813587 — DISPOSABLE THORACIC CATHETER (January 12, 1982)
  • K810515 — DISPOSABLE 2-STAGE CANNULA (April 23, 1981)
  • K810532 — DISPOSABLE STOPCOCK (April 23, 1981)
  • K810395 — PRE-BYPASS FILTER (March 5, 1981)
  • K802543 — RIDGID VENA CAVA CANNULAE (January 16, 1981)
  • K802544 — DISPOSABLE QUICK RELEASE PERFUSION ADAP (January 16, 1981)
  • K802541 — DISPOSABLE PARALLEL Y CONNECTORS (January 16, 1981)

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