HEARSAVER
FDA 510(k) clearance K962292 · decided 1996-10-29
Clearance details
- K-number
- K962292
- Device name
- HEARSAVER
- Applicant
- Emtech Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1996-06-14
- Decision date
- 1996-10-29
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- EWD
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Hardy, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (K020296) | Apothecary Products, Inc. | 2002-06-25 |
| SUPER SILIPLUGS EAR PLUGS (K972923) | Interview Medical Technology Corp. | 1997-10-27 |
| SILICONE PUTTY EAR PLUGS (K971517) | Bentec Medical, Inc. | 1997-06-02 |
| THE VIRTUAL M-332 (K960500) | Virtual Corp. | 1996-04-03 |
| DOC'S PROPLUGS EAR PLUGS (K945376) | Doc'S Proplugs, Inc. | 1995-11-14 |
| MODEL 322 CLINICAL AUDIOMETER (K930203) | Virtual Corp. | 1993-07-08 |
| #903 SILAFLEX II (K915739) | Flents Products Co., Inc. | 1992-06-30 |
| SEAL-RITE SILICONE EAR PLUG (K910177) | Flents Products Co., Inc. | 1991-06-24 |
| DOC'S PROPLUGS EAR PLUGS (K862045) | Doc'S Proplugs, Inc. | 1987-04-10 |
| MEDCO CUSTOM EAR PROTECTOR MOLD KIT (K821187) | Santa Barbara Medco, Inc. | 1982-05-27 |
| BILSOM PROPP (K791608) | Bilson International, Inc. | 1979-10-10 |
| EAR STOPPLES FOR NOISE ATTENTION (K781907) | Crown Delta Corp. | 1978-11-22 |
Recalls involving this device
No recalls on record reference this clearance.