SELF SEAL STERILIZATION POUCH
FDA 510(k) clearance K071886 · decided 2007-12-27
Clearance details
- K-number
- K071886
- Device name
- SELF SEAL STERILIZATION POUCH
- Applicant
- Shanghai Jianzhong Medical Packaging Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2007-07-09
- Decision date
- 2007-12-27
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- FRG
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shanghai, CN
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.