Protector, Hearing (Insert)
The insert hearing protector is a device worn in the ear canal to attenuate ambient noise and protect hearing from damage due to excessive sound exposure. This product code (EWD) is currently FDA unclassified, meaning the device has not been formally assigned to Class 1, 2, or 3 and is subject to an ongoing classification process. The product code is EWD, reviewed by the Ear, Nose, Throat panel; no regulation number or medical specialty is currently assigned. No implant or life-sustaining flags apply.
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Basic Information
- Product Code
- EWD
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- EN
- Submission Type
- 7
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 14 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K020296 | ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 | Jun 25, 2002 | Substantially Equivalent | Apothecary Products, Inc. |
| K972923 | SUPER SILIPLUGS EAR PLUGS | Oct 27, 1997 | Substantially Equivalent | Interview Medical Technology Corp. |
| K971517 | SILICONE PUTTY EAR PLUGS | Jun 02, 1997 | Substantially Equivalent | Bentec Medical, Inc. |
| K962292 | HEARSAVER | Oct 29, 1996 | Substantially Equivalent | Emtech Laboratories |
| K960500 | THE VIRTUAL M-332 | Apr 03, 1996 | Substantially Equivalent | Virtual Corp. |
| K945376 | DOC'S PROPLUGS EAR PLUGS | Nov 14, 1995 | Substantially Equivalent | Doc'S Proplugs, Inc. |
| K930203 | MODEL 322 CLINICAL AUDIOMETER | Jul 08, 1993 | Substantially Equivalent | Virtual Corp. |
| K915739 | #903 SILAFLEX II | Jun 30, 1992 | Substantially Equivalent | Flents Products Co., Inc. |
| K910177 | SEAL-RITE SILICONE EAR PLUG | Jun 24, 1991 | Substantially Equivalent | Flents Products Co., Inc. |
| K862045 | DOC'S PROPLUGS EAR PLUGS | Apr 10, 1987 | Substantially Equivalent | Doc'S Proplugs, Inc. |
| K821187 | MEDCO CUSTOM EAR PROTECTOR MOLD KIT | May 27, 1982 | Substantially Equivalent | Santa Barbara Medco, Inc. |
| K791608 | BILSOM PROPP | Oct 10, 1979 | Substantially Equivalent | Bilson International, Inc. |
| K781907 | EAR STOPPLES FOR NOISE ATTENTION | Nov 22, 1978 | Substantially Equivalent | Crown Delta Corp. |
| K781491 | PRO-MOLD, CUSTOM EAR | Sep 27, 1978 | Substantially Equivalent | Mcghan Medical Corp. |
FEI Numbers
This FDA classification entry is associated with 54 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 54 registration numbers. Click on an entry to view related FDA registrations.