Atlas FDA

SHANGHAI GANGHAI MODEL GIKO 1400

FDA 510(k) clearance K063334 · decided 2006-12-08

Clearance details

K-number
K063334
Device name
SHANGHAI GANGHAI MODEL GIKO 1400
Applicant
Shanghai Gangkai Purifying Products Co., Ltd.
Decision
Substantially Equivalent
Date received
2006-11-06
Decision date
2006-12-08
Days to decision
32 days
Clearance type
Abbreviated
Product code
MSH
Device class
2
Regulation number
878.4040
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Vero Beach, FL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.