FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
DOC'S PROPLUGS EAR PLUGS
K Number: K945376
·
Decision Nov 14, 1995
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
13
Applicant Total
2
Review Days
389
Basic Information
- Device Name
- DOC'S PROPLUGS EAR PLUGS
- K Number
- K945376
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- DOC'S PROPLUGS, INC.
- Date Received
- October 21, 1994
- Decision Date
- November 14, 1995
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EWD), ordered by most recent decision date.
ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057
FDA 510(k)
FDA Unclassified
·Unknown
SUPER SILIPLUGS EAR PLUGS
FDA 510(k)
FDA Unclassified
·Unknown
SILICONE PUTTY EAR PLUGS
FDA 510(k)
FDA Unclassified
·Unknown
HEARSAVER
FDA 510(k)
FDA Unclassified
·Unknown
THE VIRTUAL M-332
FDA 510(k)
FDA Unclassified
·Unknown
MODEL 322 CLINICAL AUDIOMETER
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by DOC'S PROPLUGS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K862045 | DOC'S PROPLUGS EAR PLUGS | Apr 10, 1987 | Substantially Equivalent |