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510(k) K880647

ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) by Fred Sammons, Inc. — Product Code HOX

K880647 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "ADULT PERCEPTUAL MOTOR PUZZLES (5331-01)". The FDA issued a decision of Substantially Equivalent on April 1, 1988. The device falls under product code HOX (Chart, Visual Acuity), a Class I device regulated under 21 CFR 886.1150. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1988
Date Received
February 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Chart, Visual Acuity
Device Class
Class I
Regulation Number
886.1150
Review Panel
OP
Submission Type

Other clearances by Fred Sammons, Inc.

  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K831543 — ADJUST. WEIGHTS-BK5171-05,10,20 BEOK (June 24, 1983)
  • K831550 — FINGER BONIOMETER BK7506 (June 24, 1983)
  • K831553 — LEG DRAINAGE BAG STRAP BK6011 (June 16, 1983)
  • K831540 — COMPRESSOGRIP ELASTIC STUMP SHRINKER# (June 8, 1983)
  • K831552 — SORBOTHANE VISCO INNER SOLE PAD (June 8, 1983)

Other clearances for product code HOX

  • K100095 — CENTRAL VISION ANALYZER MODEL 1000 (May 10, 2010)
  • K944156 — HEINE LAMBDA 100 (January 12, 1995)
  • K881971 — OCCU-TECH VISION TEST (November 25, 1988)
  • K883337 — PL 20/20 INFANT VISION TESTER (October 31, 1988)
  • K882634 — VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE (July 15, 1988)
  • K881358 — PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM (June 27, 1988)
  • K881059 — MCT 8000 (MULTI-VISION CONTRAST TESTER) (April 4, 1988)
  • K881023 — VCTS 6500 SYSTEM (April 1, 1988)
  • K881022 — VCTS MARKETING PROGRAM SYSTEM (April 1, 1988)
  • K881021 — VCTS 700S SYSTEM (April 1, 1988)

FDA data resources