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510(k) K802285

OHIO THORACIC SUCTION REGULATOR by Ohio Medical Products — Product Code KOP

K802285 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "OHIO THORACIC SUCTION REGULATOR". The FDA issued a decision of Substantially Equivalent on October 3, 1980. The device falls under product code KOP (Adhesive, Denture, Karaya), a Class I device regulated under 21 CFR 872.3450. Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1980
Date Received
September 19, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Denture, Karaya
Device Class
Class I
Regulation Number
872.3450
Review Panel
DE
Submission Type

Other clearances by Ohio Medical Products

  • K841733 — OHIO WASTE GAS SCAVENGING RESERVOIR (July 11, 1984)
  • K842003 — OHIO WASTE GAS SCAVENGING INTERFACE (May 23, 1984)
  • K840356 — OHIO UNITROL II ANESTHESIA GAS MACHINE (April 20, 1984)
  • K841274 — BAG-TO-VENTILATOR SELECTOR VALVE (April 13, 1984)
  • K840857 — OHIO 3000 INFANT WARMER SYSTEM (March 23, 1984)
  • K840858 — OHIO 3300 INFANT WARMER SYSTEM (March 23, 1984)
  • K840967 — OHIO HEAT REFLECTING PATCH (March 23, 1984)
  • K840453 — MEDISHIELD PVM RESPIROMETER (March 2, 1984)
  • K840452 — PREMIUM DABM DISPOS. ANES. BREATH MASK (February 17, 1984)
  • K833335 — MODULUS II ANESTHESIA GAS MACHINE (November 14, 1983)

FDA data resources