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510(k) K823598

LARGE TERRYCLOTH BIB by Fred Sammons, Inc.

K823598 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "LARGE TERRYCLOTH BIB". The FDA issued a decision of Substantially Equivalent on Feb 3, 1983. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Feb 3, 1983
Date Received
Dec 6, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Fred Sammons, Inc.

  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (Apr 1, 1988)
  • K831549 — ARM SLINGS (Jun 30, 1983)
  • K831548 — SPLINTS (Jun 27, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (Jun 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (Jun 24, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (Jun 24, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (Jun 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (Jun 16, 1983)
  • K831546 — ADAPTIVE PENS & LAP DESK (Jun 8, 1983)

FDA data resources