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510(k) K951300

NEZHAT-DORSEY THERMAL RETENTION SYSTEM by American Hydro-Surgical Instruments, Inc. — Product Code LHC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 1995
Date Received
March 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Warmer, Irrigation Solution
Device Class
Class I
Regulation Number
890.5950
Review Panel
HO
Submission Type

Other clearances by American Hydro-Surgical Instruments, Inc.

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  • K953481 — NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER (August 16, 1995)
  • K952070 — NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TR (July 26, 1995)
  • K946380 — NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOUT PUNCTURE CANNULA ( (July 6, 1995)
  • K950499 — NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS (June 16, 1995)
  • K951119 — NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM (June 13, 1995)
  • K952421 — NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS (June 8, 1995)
  • K951733 — NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COAGULATION HAND CONTRO (May 31, 1995)
  • K951732 — NEZHAT-DORESEY PENCIL-GRIP HANDLES (May 24, 1995)
  • K951731 — NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS (May 16, 1995)

Other clearances for product code LHC

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  • K150190 — IntraTemp Solution Warmer (February 26, 2015)
  • K142173 — NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE (December 30, 2014)
  • K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE (August 28, 2014)
  • K083417 — INTRATEMP SOLUTION WARMER (January 13, 2009)
  • K080609 — SWC/DWC WARMING CABINETS (June 13, 2008)
  • K051819 — C CHANGE SOLUTION WARMER (August 15, 2005)
  • K023283 — 1075LD HUSH-SLUSH (November 13, 2002)
  • K023282 — ORS-3000LD (November 13, 2002)