FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PODIATRIC MATERIAL
K Number: K940132
·
Decision Sep 29, 1994
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
1
Applicant Total
18
Review Days
269
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Basic Information
- Device Name
- PODIATRIC MATERIAL
- K Number
- K940132
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3475
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Crown Delta Corp.
- Date Received
- January 3, 1994
- Decision Date
- September 29, 1994
- Product Code
- MNE
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| MNE | Orthosis, Moldable, Supportive, Skin Protective | FDA class 1 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MNE), ordered by most recent decision date.
View allOther Clearances by Crown Delta Corp.
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| K041028 | CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL | May 14, 2004 | Substantially Equivalent |
| K955288 | HEARING AID IMPRESSION MATERIAL | Feb 2, 1996 | 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 |
| K843145 | TWO COMPONENT RTV VINYL SILICONE MATER | Oct 18, 1984 | Substantially Equivalent |