510(k) K011338
- Device
- OTO-CEM
- Applicant
- OTOTECH, INC.
- 510(k) number
- K011338
- Product code
- NEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-13
- Date received
- 2001-05-02
- Regulation
- 872.3275
- Classification name
- Cement, Ear, Nose And Throat
- Medical specialty
- Dental
- Review panel
- Ear Nose & Throat
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL G FARROW
- Address
- 1625 K St. NW Suite 1000 Washington DC US 20006 20006
FDA Registration Numbers#
- 3012118649
- 1037007
- 1450662
- 1424263
- 1052728
- 3004007782
- 1032347
- 1928237
- 3011050570
- 2029275
Source Documents#
Other 510(k) Records For Product Code NEA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K140644 | PROCEM | Ototronix, LLC | 2014-06-19 |
| K080032 | ENVOYCEM, MODEL 1640 | Envoy Medical Corporation | 2008-02-28 |
| K060750 | STRYKER INJECTABLE CEMENT | Stryker Cmf | 2006-04-19 |
| K042516 | OTOMIMIX | Walter Lorenz Surgical, Inc. | 2004-11-08 |
| K003567 | SERENOCEM, MODEL BC 010 | Corinthian Medical , Ltd. | 2001-02-12 |
Legacy Summary#
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FDA Review#
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