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510(k) K810452

NON-POWERED COMMUNICATION SYSTEMS by Fred Sammons, Inc. — Product Code ILP

K810452 is an FDA 510(k) premarket notification submitted by Fred Sammons, Inc. for the device "NON-POWERED COMMUNICATION SYSTEMS". The FDA issued a decision of Substantially Equivalent on March 4, 1981. The device falls under product code ILP (System, Communication, Non-Powered), a Class I device regulated under 21 CFR 890.3700. Fred Sammons, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 1981
Date Received
February 19, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Communication, Non-Powered
Device Class
Class I
Regulation Number
890.3700
Review Panel
PM
Submission Type

Other clearances by Fred Sammons, Inc.

  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K880647 — ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) (April 1, 1988)
  • K831549 — ARM SLINGS (June 30, 1983)
  • K831548 — SPLINTS (June 27, 1983)
  • K831544 — DELUXE TRACTION EXERCISE GLOVE BK5035 (June 24, 1983)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (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)

Other clearances for product code ILP

  • K844890 — TELL ME TAGS - NONPOWERED COMMUNICATION SYS (March 8, 1985)
  • K840112 — SPEECH TEACHER (March 22, 1984)
  • K831546 — ADAPTIVE PENS & LAP DESK (June 8, 1983)
  • K823625 — MOUTH STICK KIT (December 30, 1982)
  • K823608 — PICTURES & WORD IDENTIFICATION CVA PAT (December 30, 1982)
  • K823612 — ADJ. WOODEN BOARD FOR WRITING (December 30, 1982)
  • K823624 — HOLDER FOR MOUTH STICK (December 30, 1982)
  • K823609 — KIT OF WORDS & LTRS TO RE-LEARN-BK4014 (December 22, 1982)
  • K823610 — BK-4015 ECONOMY COMMUNICATION SHEET (December 22, 1982)
  • K823617 — PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR (December 22, 1982)

FDA data resources