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510(k) K760316

REGULATORS, LOW SUCTION by Harris-Lake, Inc. — Product Code KDP

K760316 is an FDA 510(k) premarket notification submitted by Harris-Lake, Inc. for the device "REGULATORS, LOW SUCTION". The FDA issued a decision of Substantially Equivalent on August 4, 1976. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Harris-Lake, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1976
Date Received
July 26, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Harris-Lake, Inc.

  • K761293 — RESPIRATORY HUMIDIFIER (January 3, 1977)
  • K761294 — RESPIRATORY BLOWER (January 3, 1977)
  • K761295 — RESP. AIR TEMP. CONTROL & HAZARD MON. (December 30, 1976)
  • K760333 — JAR, COLLECTOR FOR SUCTION SYSTEMS (October 27, 1976)
  • K760314 — FLOWMETER, OXYGEN (August 4, 1976)
  • K760317 — REGULATORS, HIGH SUCTION (August 4, 1976)

Other clearances for product code KDP

  • K013976 — BOEHRINGER MRI SUCTION REGULATORY (January 8, 2002)
  • K944479 — PM3300 INTERMITTENT VACUUM (December 22, 1994)
  • K942747 — MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (July 21, 1994)
  • K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (March 28, 1994)
  • K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS (July 27, 1993)
  • K922817 — PM3000 & PM3100 VACUUM REGULATOR (March 4, 1993)
  • K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR (October 19, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
  • K850200 — SUCTION REGULATOR 7700 SERIES (March 4, 1985)

FDA data resources