HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
FDA 510(k) clearance K150916 · decided 2015-11-10
Clearance details
- K-number
- K150916
- Device name
- HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
- Applicant
- Hem Con Medical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-04-06
- Decision date
- 2015-11-10
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- QSY
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Portland, OR, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.