Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
FDA 510(k) clearance K182184 · decided 2019-10-10
Clearance details
- K-number
- K182184
- Device name
- Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
- Applicant
- Mdk (Shanghai) Medical Packing Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-13
- Decision date
- 2019-10-10
- Days to decision
- 423 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
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.