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510(k) K781759

RESCAL by Diemolding Corp. — Product Code BZA

K781759 is an FDA 510(k) premarket notification submitted by Diemolding Corp. for the device "RESCAL". The FDA issued a decision of Substantially Equivalent on November 27, 1978. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Diemolding Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1978
Date Received
October 16, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Connector, Airway (Extension)
Device Class
Class I
Regulation Number
868.5810
Review Panel
AN
Submission Type

Other clearances by Diemolding Corp.

  • K962749 — THERAPEP W/MOUTHPIECE, W/PEDIATRIC MASK, W/SMALL MASK, W/LARGE MASK, RESISTOR/PO (October 10, 1996)
  • K961455 — MEDSHIELD/AEROCHAMBER (July 25, 1996)
  • K902713 — ACCESS. KIT FOR THE BIOSURGE SYNCHRONOUS AUTOTRANS (July 25, 1990)
  • K902114 — CUFF-MATE 2 ENDOTRACHEAL CUFF INFLATOR & MONITOR (July 18, 1990)
  • K900754 — RESPIREX 2 (March 15, 1990)
  • K893791 — BREATHING MOUTHPIECE (June 23, 1989)
  • K780750 — O2 CONNECTOR (July 27, 1978)
  • K770369 — VACON TM (March 1, 1977)
  • K760931 — I.V. DRIP MONITOR ALARM DEVICE, MONIFLO (January 5, 1977)
  • K760636 — ORTHOMIX (October 5, 1976)

Other clearances for product code BZA

  • K083702 — TRACH-ASSIST (March 5, 2009)
  • K954383 — SURELOC CIRCUIT CONNECTOR (December 22, 1995)
  • K954197 — DISPOSABLE FLEX TUBE (October 26, 1995)
  • K953786 — UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS (September 19, 1995)
  • K952824 — NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR (July 20, 1995)
  • K951345 — DISPOSABLE AIRWAY CONNECTORS FOR GAS SAMPLING (April 14, 1995)
  • K944532 — PRIMA, INC. VENTILATOR HOSES (December 2, 1994)
  • K944535 — PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS (November 29, 1994)
  • K944534 — PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS (November 29, 1994)
  • K942392 — AIRWAY CONNECTOR WITH FLEX TUBE (August 22, 1994)

FDA data resources