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510(k) K863767

GLASS MOUTH MIRRORS, REUSABLE by The Medical Group, Inc. — Product Code EAX

K863767 is an FDA 510(k) premarket notification submitted by The Medical Group, Inc. for the device "GLASS MOUTH MIRRORS, REUSABLE". The FDA issued a decision of Substantially Equivalent on October 30, 1986. The device falls under product code EAX (Mirror, Mouth), a Class I device regulated under 21 CFR 872.4565. The Medical Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1986
Date Received
September 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mirror, Mouth
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by The Medical Group, Inc.

  • K911246 — THE MEDISCUS PEDCARE MANAGEMENT SYSTEM-MODEL 2 (June 6, 1991)
  • K901295 — PULMONAIR 40 PATIENT MANAGEMENT SYSTEM (March 30, 1990)
  • K881843 — PEDIATRIC HOSPITAL BED (October 26, 1988)
  • K881844 — MAGNUM 800(TM) MANAGEMENT SYSTEM (July 14, 1988)
  • K870283 — 3 X 3 SPONGES, NON-STERILE (February 24, 1987)
  • K870282 — 4 X 4 SPONGES, NON-STERILE (February 24, 1987)
  • K870284 — TRIANGULAR BANDAGE (February 24, 1987)
  • K870285 — THERMOMETER SHEATHES, STERILE (GLASS) (February 12, 1987)
  • K863766 — DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (October 30, 1986)
  • K863769 — EVACUATOR TIPS (October 30, 1986)

Other clearances for product code EAX

  • K946073 — ORALVUE DENTAL MIRROR (February 16, 1995)
  • K935906 — RANIR PLAX RX (September 2, 1994)
  • K941574 — RETRO MIRROR (May 18, 1994)
  • K935687 — NIL (February 3, 1994)
  • K863766 — DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLY (October 30, 1986)
  • K833310 — FOGCUTTER DENTAL MOUTH MIRROR (May 7, 1984)
  • K841199 — FIBERGLASS MOUTH MIRRORS (April 25, 1984)
  • K833429 — PERI MIRROR/SALIVA EJECTOR (December 22, 1983)
  • K830777 — ELECTRIC MOUTH MIRROR (April 6, 1983)
  • K821777 — BEACH MOUTH MIRROR (July 6, 1982)

FDA data resources