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510(k) K821904

XOMED MANDIBULAR TRAY by Xomed, Inc. — Product Code JAZ

K821904 is an FDA 510(k) premarket notification submitted by Xomed, Inc. for the device "XOMED MANDIBULAR TRAY". The FDA issued a decision of Substantially Equivalent on July 26, 1982. The device falls under product code JAZ (Prosthesis, Facial, Mandibular Implant), a Class II device regulated under 21 CFR 874.3695. Xomed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 1982
Date Received
June 28, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Facial, Mandibular Implant
Device Class
Class II
Regulation Number
874.3695
Review Panel
EN
Submission Type

Other clearances by Xomed, Inc.

  • K002395 — MODEL 30 CLASSIC PNEUMATONOMETER (December 11, 2000)
  • K002987 — REDTRONIC XOMED MONOPOLAR ENERGIZED BLADE (December 4, 2000)
  • K002828 — XPS NITRO SYSTEM (October 17, 2000)
  • K002897 — TITANIUM MIDDLE EAR PROSTHESES (October 11, 2000)
  • K993653 — MICRO-FRANCE TROCARS AND ACCESSORIES (June 9, 2000)
  • K001148 — MEROGEL OTOLOGIC PACK (June 3, 2000)
  • K994262 — FRONTAL SINUS TREPHINATION CANNULA (February 8, 2000)
  • K992855 — XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS POWERSCULPT (January 21, 2000)
  • K993582 — MODIFICATION TO LASER-SHIELD II (January 20, 2000)
  • K993655 — MICRO-FRANCE ELECTROSURGICAL INSTRUMENTS, VARIOUS (December 21, 1999)

Other clearances for product code JAZ

  • K901923 — INVOTEC POLY-MESH MANDIBULAR TRAY (October 31, 1990)

FDA data resources