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510(k) K011338

OTO-CEM by Ototech, Inc. — Product Code NEA

K011338 is an FDA 510(k) premarket notification submitted by Ototech, Inc. for the device "OTO-CEM". The FDA issued a decision of Substantially Equivalent on September 13, 2001. The device falls under product code NEA (Cement, Ear, Nose And Throat), a Class II device regulated under 21 CFR 872.3275. Ototech, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2001
Date Received
May 2, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Ear, Nose And Throat
Device Class
Class II
Regulation Number
872.3275
Review Panel
EN
Submission Type

Other clearances by Ototech, Inc.

  • K910314 — C ABRA MODEL LINEAR, LOW DR. CUSTOM CANAL HEAR AID (March 18, 1991)
  • K910313 — ABRA IPC MODEL INPUT COMPRES AGCCUST ITE HEAR AID (March 18, 1991)
  • K910311 — ABRA MODEL LINE LOW DRAIN CUST IN-THE-EAR HEAR AID (March 18, 1991)
  • K910312 — C ABRA MODEL LINEAR, LOW DRAIN CUST CANAL HEAR AID (March 18, 1991)

Other clearances for product code NEA

  • K140644 — PROCEM (June 19, 2014)
  • K080032 — ENVOYCEM, MODEL 1640 (February 28, 2008)
  • K060750 — STRYKER INJECTABLE CEMENT (April 19, 2006)
  • K042516 — OTOMIMIX (November 8, 2004)
  • K003567 — SERENOCEM, MODEL BC 010 (February 12, 2001)

FDA data resources