FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CRADLING SYSTEM
K Number: K761032
·
Decision Jan 26, 1977
Classifications
1
FEI Numbers
61
Registration Numbers
61
Same Product Code
183
Applicant Total
5
Review Days
72
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Basic Information
- Device Name
- CRADLING SYSTEM
- K Number
- K761032
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6880
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Medin Corp.
- Date Received
- November 15, 1976
- Decision Date
- January 26, 1977
- Product Code
- FLE
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FLE | Sterilizer, Steam | FDA class 2 | General Hospital |
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Other Clearances by Medin Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K921020 | HARGIS SELF RETRACTION SYSTEM | Jul 2, 1993 | Substantially Equivalent |
| K921019 | HARGIS RECTAL SELF RETRATION SYSTEM | Jul 2, 1993 | Substantially Equivalent |
| K921017 | HARGIS SR2 SELF-RETRACTION SYSTEM | Jul 2, 1993 | Substantially Equivalent |
| K833343 | STERILIZATION CONTAINER | Nov 3, 1983 | Substantially Equivalent |