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510(k) K844890

TELL ME TAGS - NONPOWERED COMMUNICATION SYS by Mina Manufacturers, Inc. — Product Code ILP

K844890 is an FDA 510(k) premarket notification submitted by Mina Manufacturers, Inc. for the device "TELL ME TAGS - NONPOWERED COMMUNICATION SYS". The FDA issued a decision of Substantially Equivalent on March 8, 1985. The device falls under product code ILP (System, Communication, Non-Powered), a Class I device regulated under 21 CFR 890.3700.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1985
Date Received
December 17, 1984
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 for product code ILP

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  • 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)
  • K823617 — PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR (December 22, 1982)
  • K823614 — FLEXIBLE HOLDER TO HOLD PHONE RECEIVER (December 22, 1982)
  • K823609 — KIT OF WORDS & LTRS TO RE-LEARN-BK4014 (December 22, 1982)
  • K823610 — BK-4015 ECONOMY COMMUNICATION SHEET (December 22, 1982)

FDA data resources