FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VINYL ADDITION SILICONE SYSTEM
K Number: K926150
·
Decision Jul 14, 1993
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
18
Review Days
219
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Basic Information
- Device Name
- VINYL ADDITION SILICONE SYSTEM
- K Number
- K926150
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Crown Delta Corp.
- Date Received
- December 7, 1992
- Decision Date
- July 14, 1993
- Product Code
- ESD
- Advisory Committee
- Ear, Nose, Throat
- 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
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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 |
| 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 |
| K843145 | TWO COMPONENT RTV VINYL SILICONE MATER | Oct 18, 1984 | Substantially Equivalent |