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510(k) K874022

PHARMASEAL WOUND IRRIGATION DEVICE by American Pharmaseal Div. Ahsc — Product Code FQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1987
Date Received
October 2, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lavage, Jet
Device Class
Class II
Regulation Number
880.5475
Review Panel
HO
Submission Type

Other clearances by American Pharmaseal Div. Ahsc

  • K874517 — PHARMASEAL RUBBER URETHRAL CATHETER (December 3, 1987)
  • K874045 — PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER (December 3, 1987)
  • K873359 — AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE (November 6, 1987)
  • K872228 — PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM (September 4, 1987)
  • K872917 — JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER (August 11, 1987)
  • K871429 — ANTIMICROBIAL FOLEY CATHETER (August 10, 1987)
  • K871770 — AMERICAN PHARMASEAL WOUND DRESSING (June 26, 1987)
  • K870387 — EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE (May 8, 1987)
  • K870977 — PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE (April 1, 1987)
  • K870704 — CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET (March 27, 1987)

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