510(k) K834384

MODULAR EXTREMITY CASTING SUPPORT by Buckman Co., Inc. — Product Code LGG

K834384 is an FDA 510(k) premarket notification submitted by Buckman Co., Inc. for the device "MODULAR EXTREMITY CASTING SUPPORT". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code LGG (Instrument, Cast Application/Removal, Manual), a Class I device regulated under 21 CFR 888.5980. Buckman Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
December 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Cast Application/Removal, Manual
Device Class
Class I
Regulation Number
888.5980
Review Panel
OR
Submission Type