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510(k) K843906

SNYDER HEMOVAC WOUND DRAINAGE DEVICES by Snyder Laboratories, Inc. — Product Code GBS

K843906 is an FDA 510(k) premarket notification submitted by Snyder Laboratories, Inc. for the device "SNYDER HEMOVAC WOUND DRAINAGE DEVICES". The FDA issued a decision of Substantially Equivalent on November 5, 1984. The device falls under product code GBS (Catheter, Ventricular, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4200. Snyder Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1984
Date Received
October 3, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Snyder Laboratories, Inc.

  • K821321 — SNYDER DEBRIBEMENT SYSTEM LDP-1 (August 6, 1982)
  • K800861 — SNYDER HEMOVAC CHEST DRAINAGE SOLUTION (May 2, 1980)
  • K800543 — SNYDER HYSTERECTOMY Y TUBE KIT (April 16, 1980)
  • K800578 — SURGIVAC TM (April 16, 1980)
  • K800577 — SNYDER HEMOVAC TM VENTED WOUND KIT (April 16, 1980)
  • K800542 — 100 ML SNYDER HEMOVAC (April 2, 1980)
  • K790607 — GREENLINE IRRIGATION TRAYS (May 11, 1979)
  • K790419 — YANKAUER & POODLE SUCTION INSTRUMENTS (April 23, 1979)
  • K790420 — SUCTION CONNECTING TUBING (April 23, 1979)
  • K790606 — CATHETERS, GREENLINE SUCTION (April 23, 1979)

Other clearances for product code GBS

  • K912645 — ATRIUMS PDR THORACIC CATHETER (September 13, 1991)
  • K883887 — AXIOM ATRAUM WOUND DRAINS (February 17, 1989)
  • K881873 — INTRODUCTION/DRAINAGE CATHETER & ACCESS (May 18, 1988)
  • K880895 — URESIL WOUND DRAIN TROCAR (March 14, 1988)
  • K880376 — NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP (February 16, 1988)
  • K873377 — CLOSED CHEST DRAINAGE SET W/SUTURES (October 28, 1987)
  • K872460 — AN3000 MAHONEY DRAIN (July 23, 1987)
  • K872457 — AN3500 WORTH DRAIN (July 21, 1987)
  • K872459 — AN3100 MULHOLLAND DRAIN (July 21, 1987)
  • K870015 — HCI ALL PURPOSE DRAIN/CATHETER SET (February 6, 1987)

FDA data resources