FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
EAR STOPPLES FOR NOISE ATTENTION
K Number: K781907
·
Decision Nov 22, 1978
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
13
Applicant Total
18
Review Days
8
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Basic Information
- Device Name
- EAR STOPPLES FOR NOISE ATTENTION
- K Number
- K781907
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Crown Delta Corp.
- Date Received
- November 14, 1978
- Decision Date
- November 22, 1978
- 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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Other Clearances by Crown Delta Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K122974 | TRYOUT-VPS HOLDING PASTE | May 17, 2013 | Substantially Equivalent |
| K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | May 14, 2004 | Substantially Equivalent |
| K955288 | HEARING AID IMPRESSION MATERIAL | Feb 2, 1996 | Substantially Equivalent |
| K940132 | PODIATRIC MATERIAL | Sep 29, 1994 | Substantially Equivalent |
| K930248 | VINYL POLYSILOXANE 2 COMPONENT VULCANIZING SYSTEM | Jan 7, 1994 | Substantially Equivalent |
| K926150 | VINYL ADDITION SILICONE SYSTEM | Jul 14, 1993 | Substantially Equivalent |
| K901991 | SILICONE ELASTOMER PUTTY | Sep 14, 1990 | Substantially Equivalent |
| K901990 | VINYL SILICONE ELASTOMER MATERIAL | Sep 14, 1990 | Substantially Equivalent |
| K872745 | VINYL POLYSILOXANE IMPRESSION SYSTEM | Jul 21, 1987 | Substantially Equivalent |
| K871409 | VINYL POLYSILOXANE IMPRESSION SYSTEM | Jun 11, 1987 | Substantially Equivalent |