510(k) K864816
K864816 is an FDA 510(k) premarket notification submitted by Currie Medical Specialties, Inc. for the device "CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE". The FDA issued a decision of Substantially Equivalent on January 8, 1987. Currie Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 8, 1987
- Date Received
- December 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No