510(k) K895587

CROSS MEDICAL PRODUCT PEDICLE AWL by Cross Medical Products, Inc. — Product Code HWJ

K895587 is an FDA 510(k) premarket notification submitted by Cross Medical Products, Inc. for the device "CROSS MEDICAL PRODUCT PEDICLE AWL". The FDA issued a decision of Substantially Equivalent on January 4, 1990. The device falls under product code HWJ (Awl), a Class I device regulated under 21 CFR 888.4540. Cross Medical Products, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 1990
Date Received
September 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Awl
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type