B-D GUARDIAN NESTABLE SHARPS COLLECTORS

Needle, Hypodermic, Single Lumen

MED-SAFE SYSTEMS, INC.

The following data is part of a premarket notification filed by Med-safe Systems, Inc. with the FDA for B-d Guardian Nestable Sharps Collectors.

Pre-market Notification Details

Device IDK943134
510k NumberK943134
Device Name:B-D GUARDIAN NESTABLE SHARPS COLLECTORS
ClassificationNeedle, Hypodermic, Single Lumen
Applicant MED-SAFE SYSTEMS, INC. 4665 NORTH AVE. Oceanside,  CA  92056 -3590
ContactVirginia M Shillington
CorrespondentVirginia M Shillington
MED-SAFE SYSTEMS, INC. 4665 NORTH AVE. Oceanside,  CA  92056 -3590
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-06-29
Decision Date1994-11-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903056460 K943134 000
00382903053292 K943134 000
00382903053438 K943134 000
00382903053445 K943134 000
50382903050586 K943134 000
50382903050784 K943134 000
50382903053280 K943134 000
50382903053297 K943134 000
50382903053433 K943134 000
50382903053440 K943134 000
00382903054565 K943134 000
00382903054572 K943134 000
00382903054640 K943134 000
00382903054657 K943134 000
00382903054800 K943134 000
00382903056163 K943134 000
00382903056347 K943134 000
00382903050581 K943134 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.