FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
SILICONE PUTTY EAR PLUGS
K Number: K971517
·
Decision Jun 2, 1997
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
13
Applicant Total
3
Review Days
38
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Basic Information
- Device Name
- SILICONE PUTTY EAR PLUGS
- K Number
- K971517
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Bentec Medical, Inc.
- Date Received
- April 25, 1997
- Decision Date
- June 2, 1997
- Product Code
- EWD
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| EWD | Protector, Hearing (Insert) | FDA unclassified | Unknown |
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