FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INVOTEC POLY-MESH MANDIBULAR TRAY
K Number: K901923
·
Decision Oct 31, 1990
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
16
Review Days
184
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Basic Information
- Device Name
- INVOTEC POLY-MESH MANDIBULAR TRAY
- K Number
- K901923
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.3695
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Invotec International, Inc.
- Date Received
- April 30, 1990
- Decision Date
- October 31, 1990
- Product Code
- JAZ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JAZ | Prosthesis, Facial, Mandibular Implant | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAZ), ordered by most recent decision date.
View allOther Clearances by Invotec International, Inc.
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| K971000 | EPISTAXIS NASAL PACK | May 14, 1997 | Substantially Equivalent |
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| K911040 | INVOTEC MICROSCOPE DRAPE | Jun 3, 1991 | Substantially Equivalent |
| K911039 | INVOTEC EAR DRAPE | May 13, 1991 | Substantially Equivalent |