FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR TOTAL HIP PACK
K Number: K960213
·
Decision Apr 12, 1996
Classifications
1
FEI Numbers
194
Registration Numbers
194
Same Product Code
321
Applicant Total
21
Review Days
87
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Basic Information
- Device Name
- CPR TOTAL HIP PACK
- K Number
- K960213
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6850
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Custom Pack Reliability
- Date Received
- January 16, 1996
- Decision Date
- April 12, 1996
- Product Code
- FRG
- 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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | FDA class 2 | General Hospital |
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Other Clearances by Custom Pack Reliability
| K Number | Device Name | ||
|---|---|---|---|
| K960205 | CPR TRACHEOTOMY CARE TRAY | Aug 27, 1996 | Substantially Equivalent |
| K960243 | CPR C-SECTION DELIVERY PACK | May 23, 1996 | Substantially Equivalent |
| K960239 | CPR D & C TRAY | May 23, 1996 | Substantially Equivalent |
| K960216 | CPR SUCTION CATHETER KIT | Apr 15, 1996 | Substantially Equivalent |
| K960211 | CPR TOTAL KNEE PACK | Apr 12, 1996 | Substantially Equivalent |
| K960210 | CPR ORTHO HAND PACK | Apr 12, 1996 | Substantially Equivalent |
| K960206 | CPR DRESSING CHANGE TRAY | Apr 12, 1996 | Substantially Equivalent |
| K960209 | CPR HEART PACK | Apr 4, 1996 | Substantially Equivalent |
| K960214 | CPR FOLEY CAHTETER KIT | Apr 1, 1996 | Substantially Equivalent |
| K960212 | CPR IRRIGATION TRAY | Apr 1, 1996 | Substantially Equivalent |