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510(k) K820517

CONSTRUCTA FOAM by Alimed, Inc.

K820517 is an FDA 510(k) premarket notification submitted by Alimed, Inc. for the device "CONSTRUCTA FOAM". The FDA issued a decision of Substantially Equivalent on March 10, 1982. Alimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1982
Date Received
February 25, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Alimed, Inc.

  • K963527 — UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS (October 31, 1996)
  • K963528 — ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STR (October 29, 1996)
  • K963526 — STRAP WEDGE (October 28, 1996)
  • K920487 — MINI VIBRATOR (February 18, 1992)
  • K840156 — PROTECTA COAT SPONGES (March 23, 1984)
  • K822650 — SUPER DONUT (September 30, 1982)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K820516 — ARTERIAL CANALIZATION DEVICE (April 15, 1982)
  • K801743 — PLASTAZOTE SHOE (August 7, 1980)
  • K791189 — ECHO CARDIOGRAM PAD (July 17, 1979)

FDA data resources