FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
K Number: K964619
·
Decision Jan 22, 1997
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
281
Applicant Total
21
Review Days
65
Basic Information
- Device Name
- DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)
- K Number
- K964619
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.6640
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SDS DENTAL, INC.
- Date Received
- November 18, 1996
- Decision Date
- January 22, 1997
- Product Code
- EIA
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EIA | Unit, Operative Dental | FDA class 1 | Dental |
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