JJ Series Container System
FDA 510(k) clearance K192056 · decided 2020-03-27
Clearance details
- K-number
- K192056
- Device name
- JJ Series Container System
- Applicant
- Aesculap, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-08-01
- Decision date
- 2020-03-27
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Center Valley, PA, US
- Third-party review
- No
- Expedited review
- No
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| PAL Sterilization Case (K243589) | Microaire Surgical Instruments, LLC | 2025-06-20 |
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Recalls involving this device
No recalls on record reference this clearance.