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510(k) K896256

REFLUX BED by Cozcon, Inc. — Product Code INW

K896256 is an FDA 510(k) premarket notification submitted by Cozcon, Inc. for the device "REFLUX BED". The FDA issued a decision of Substantially Equivalent on November 8, 1989. The device falls under product code INW (Table, Mechanical), a Class I device regulated under 21 CFR 890.3750.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 1989
Date Received
October 31, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Mechanical
Device Class
Class I
Regulation Number
890.3750
Review Panel
PM
Submission Type

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  • K943975 — EURO TECH PLATINUM CHIROPRACTIC TABLE (September 29, 1994)
  • K943974 — EURO TECH MARQUISE CHIROPRACTIC TABLE (September 29, 1994)
  • K940238 — TUMBLE FORMS JUNIOR TRISTANDER (March 7, 1994)
  • K932234 — PROFESSIONAL & ECONMY TILT TABLE 9500 9520 (July 22, 1993)
  • K932231 — ECONOMY HI-LOW MAT TABLE #4110 THRU 4117 (July 22, 1993)
  • K932233 — ECONOMY HI-LOW WORK TABLE (MANUAL) MODEL 3405 (July 22, 1993)
  • K932238 — ECO. HI-LOW TREATMENT TABLES VARIOUS MODEL NUMBERS (July 22, 1993)
  • K931635 — TREATMENT TABLES, MANUALLY ACTIVATED (July 21, 1993)

FDA data resources