FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DELTA-LITE
K Number: K790320
·
Decision May 18, 1979
Classifications
1
FEI Numbers
238
Registration Numbers
238
Same Product Code
36
Applicant Total
206
Review Days
92
Basic Information
- Device Name
- DELTA-LITE
- K Number
- K790320
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- JOHNSON & JOHNSON PROFESSIONALS, INC.
- Date Received
- February 15, 1979
- Decision Date
- May 18, 1979
- Product Code
- ITG
- 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 |
|---|---|---|---|
| ITG | Bandage, Cast | FDA class 1 | Physical Medicine |
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