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510(k) K771658

IDENTOFLEX by Cavitron Corp. — Product Code EHJ

K771658 is an FDA 510(k) premarket notification submitted by Cavitron Corp. for the device "IDENTOFLEX". The FDA issued a decision of Substantially Equivalent on September 12, 1977. The device falls under product code EHJ (Disk, Abrasive), a Class I device regulated under 21 CFR 872.6010. Cavitron Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1977
Date Received
August 30, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Disk, Abrasive
Device Class
Class I
Regulation Number
872.6010
Review Panel
DE
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)
  • K791277 — MODEL 6500 EXTRACTION IRRIGATION SYS (August 22, 1979)
  • K782054 — LASER, CO2 SURGICAL (January 17, 1979)

Other clearances for product code EHJ

  • K911111 — MICROMILLS, PATRIOTS, ALPHA GOLD DIAMONDS (November 19, 1991)
  • K873002 — MIN-IDENTOFLEX (August 17, 1987)
  • K790640 — HOWMEDICA BRASS CENTER DISC (May 1, 1979)

FDA data resources