510(k) K925593

NORTEC STERILE WATER FOR DEVICE IRRIGATION by North American Sterilization & Packaging Co. — Product Code LDQ

K925593 is an FDA 510(k) premarket notification submitted by North American Sterilization & Packaging Co. for the device "NORTEC STERILE WATER FOR DEVICE IRRIGATION". The FDA issued a decision of Substantially Equivalent on December 3, 1993. North American Sterilization & Packaging Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1993
Date Received
November 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No