CPR SUTURE REMOVAL KIT
FDA 510(k) clearance K960238 · decided 1996-03-28
Clearance details
- K-number
- K960238
- Device name
- CPR SUTURE REMOVAL KIT
- Applicant
- Custom Pack Reliability
- Decision
- Substantially Equivalent
- Date received
- 1996-01-16
- Decision date
- 1996-03-28
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Orlando, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.