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510(k) K911072

SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR by A & F Products — Product Code EHZ

K911072 is an FDA 510(k) premarket notification submitted by A & F Products for the device "SUPER EVACRETRACTOR, DISPOSABLE ORAL EVACUATOR". The FDA issued a decision of Substantially Equivalent on May 15, 1991. The device falls under product code EHZ (Evacuator, Oral Cavity), a Class I device regulated under 21 CFR 872.6640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 1991
Date Received
March 11, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Evacuator, Oral Cavity
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances for product code EHZ

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  • K941164 — TAP EXPRESS EJECTOR (May 18, 1994)
  • K903718 — OROSCOPE MODEL NUMBER COS-100 (November 9, 1990)
  • K892881 — DENTAL SANI-SLEEVE STERILE 60MM X 1650MM #1101 (June 23, 1989)
  • K892882 — DENTAL SANI-SLEEVE STERILE 100MM X 2200MM #1102 (June 23, 1989)
  • K880754 — DRI-CLAVE LIQUID KLEENZALL (May 12, 1988)
  • K873545 — PORTABLE FIELD DENTAL OPERATING & TREATMENT UNIT (November 20, 1987)
  • K874401 — TITANIUM SUCTION TIP (November 12, 1987)
  • K864621 — VAC - RITE RIGHT ANGLE ASPIRATOR TUBE & HOLDER (February 13, 1987)
  • K863769 — EVACUATOR TIPS (October 30, 1986)

FDA data resources