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510(k) K833132

MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY by Myo-Tronics Research, Inc. — Product Code EFH

K833132 is an FDA 510(k) premarket notification submitted by Myo-Tronics Research, Inc. for the device "MUCOSAL ADJUSTMENT PASTE LIQUID SPRAY". The FDA issued a decision of Substantially Equivalent on February 10, 1984. The device falls under product code EFH (Paper, Articulation), a Class I device regulated under 21 CFR 872.6140. Myo-Tronics Research, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1984
Date Received
September 13, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Paper, Articulation
Device Class
Class I
Regulation Number
872.6140
Review Panel
DE
Submission Type

Other clearances by Myo-Tronics Research, Inc.

  • K842224 — BNS 40 (November 19, 1984)
  • K842223 — J4 MYO-MONITOR (November 19, 1984)
  • K831364 — TESTCORP RA (May 27, 1983)
  • K830034 — MODEL EM-2 BIOELECTRIC PROCESSOR (February 9, 1983)
  • K813533 — ELECTRIC MUSCLE STIMULATOR (March 5, 1982)
  • K810528 — MODEL EM-IR (March 31, 1981)
  • K770252 — MONITOR, MYO, MODEL J3 (February 18, 1977)

Other clearances for product code EFH

  • K965026 — PFINGST PRESSURE PASTE (February 10, 1997)
  • K912632 — OCCLUDE (January 17, 1992)
  • K911259 — HYDENT (June 6, 1991)
  • K864572 — FIXTECTOR (February 12, 1987)
  • K870032 — REVISED T-SCAN SYSTEM (February 2, 1987)
  • K832647 — ARTICULATING PAPER (February 21, 1984)
  • K810498 — CENTRIC (BITE) REGISTRATION PASTE (March 17, 1981)
  • K771011 — ARTICULATING PAPER (June 20, 1977)
  • K770492 — CRACK DETECTOR, DEN-MAT (March 21, 1977)

FDA data resources