FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CPR HEART PACK
K Number: K960209
·
Decision Apr 4, 1996
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
84
Applicant Total
21
Review Days
79
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Basic Information
- Device Name
- CPR HEART PACK
- K Number
- K960209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5010
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Custom Pack Reliability
- Date Received
- January 16, 1996
- Decision Date
- April 4, 1996
- Product Code
- GAW
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GAW | Suture, Nonabsorbable, Synthetic, Polypropylene | FDA class 2 | General, Plastic Surgery |
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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 |
| K960213 | CPR TOTAL HIP PACK | Apr 12, 1996 | Substantially Equivalent |
| K960214 | CPR FOLEY CAHTETER KIT | Apr 1, 1996 | Substantially Equivalent |
| K960212 | CPR IRRIGATION TRAY | Apr 1, 1996 | Substantially Equivalent |