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510(k) K854699

TUBING SYRING by Almore Intl., Inc. — Product Code ECB

K854699 is an FDA 510(k) premarket notification submitted by Almore Intl., Inc. for the device "TUBING SYRING". The FDA issued a decision of Substantially Equivalent on January 6, 1986. The device falls under product code ECB (Unit, Syringe, Air And/Or Water), a Class I device regulated under 21 CFR 872.4565. Almore Intl., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1986
Date Received
November 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Syringe, Air And/Or Water
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Almore Intl., Inc.

  • K862851 — ALMORE FACE MASK (August 12, 1986)
  • K854692 — MONARCH II BLEACHING INSTRUMENT (May 12, 1986)
  • K854696 — OP II VISIBLE LIGHT CURING SYSTEM (March 26, 1986)
  • K854691 — DIAMOND BURS-HANDPIECE (March 25, 1986)
  • K854690 — DIAMONDS BURS-COMPOSIT FINISHING (March 25, 1986)
  • K854700 — EZ-ON TUBING CONDITIONER (LUBRICANT) (March 12, 1986)
  • K854697 — TUBING HANDPIECE REPLACEMENT (March 6, 1986)
  • K854701 — RETRACT-A-CORD (March 6, 1986)
  • K854702 — PLASTIC MOUNTING RINGS (March 6, 1986)
  • K831136 — DOUBLE BOW TOOTH SEPARATOR (June 8, 1983)

Other clearances for product code ECB

  • K942519 — UNI-SYRINGE, UNI-TIP AND ACCESS SYRINGE TIPS (August 23, 1994)
  • K931772 — SURETIP SYRINGE TIP COVER (March 7, 1994)
  • K931137 — DENTAL SYRINGE TIP (November 29, 1993)
  • K923876 — RISKONTROL SINGLE USE (April 5, 1993)
  • K923285 — PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE (September 15, 1992)
  • K920499 — SANI-TIP (May 3, 1992)
  • K911756 — POSTERIOR NASAL EPISTAXIS INSTRUMENTS (October 24, 1991)
  • K890290 — BRACE (ORAFIX SPECIAL) (March 29, 1989)
  • K863024 — SERINGA TRIPLICE S.L. (September 25, 1986)
  • K801686 — SPACELINE THREE WAY SYRINGE (August 4, 1980)

FDA data resources