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510(k) K791277

MODEL 6500 EXTRACTION IRRIGATION SYS by Cavitron Corp. — Product Code HDQ

K791277 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "MODEL 6500 EXTRACTION IRRIGATION SYS". The FDA issued a decision of Substantially Equivalent on August 22, 1979. The device falls under product code HDQ (Dilator, Cervical, Fixed Size), a Class I device regulated under 21 CFR 884.4530. Cavitron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 1979
Date Received
July 10, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dilator, Cervical, Fixed Size
Device Class
Class I
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Cavitron Corp.

  • K811582 — THE PLACER (July 28, 1981)
  • K810207 — MINOR SURGERY LIGHT (February 13, 1981)
  • K802928 — SPIROMETRIC COMPUTER #SC-10 (December 17, 1980)
  • K801623 — CAVITRON ULTRASONIC SURG. ASPIR. CUSA (November 18, 1980)
  • K801877 — SLIT LAMP ATTACHMENT (September 16, 1980)
  • K800869 — MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA (May 28, 1980)
  • K800722 — AUTO-FIELD D AUTOMATED VISUAL DETECTOR (April 29, 1980)
  • K791585 — MODEL G-61 ULTRASONIC DENTAL UNIT (September 19, 1979)
  • K782054 — LASER, CO2 SURGICAL (January 17, 1979)
  • K782065 — LASER, PHOTOCOAGULATION (December 28, 1978)

Other clearances for product code HDQ

  • K930034 — CERVICAL DILATORS:PRATT,HAWKIN,KLEEGMAN,DENNISTON (February 24, 1994)
  • K896701 — TEFLON CERVICAL ACCESS SET (September 13, 1990)
  • K891029 — CERVICAL DILATORS PRATT,HAWKIN,KLEEGMAN,DENN.,VALL (March 17, 1989)
  • K890377 — FIXED-SIZE UTERINE DILATOR (February 13, 1989)
  • K811568 — CERVICAL DILATOR (July 16, 1981)

FDA data resources