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510(k) K882229

AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS by Biologics Intl., Inc. — Product Code IOQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1988
Date Received
May 20, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Flotation Therapy, Powered
Device Class
Class II
Regulation Number
890.5170
Review Panel
PM
Submission Type

Other clearances by Biologics Intl., Inc.

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  • K811375 — BI-RA SLIDE TEST (June 12, 1981)
  • K811374 — BI-CRP LATEX TEST (June 12, 1981)
  • K800605 — ANA LATEX SLIDE TEST (April 2, 1980)
  • K791609 — BE-SURE (October 2, 1979)
  • K791607 — BETA-CELL (September 24, 1979)
  • K790898 — PREG-TEX (July 30, 1979)

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  • K970295 — FLEXICAIR EXLIPSE PLUS (May 16, 1997)
  • K943433 — TOTAL CONTACT SEAT RIPPLE SYSTEM (July 31, 1995)
  • K951001 — FLEXICAIR EXLIPSE (June 27, 1995)