The following data is part of a premarket notification filed by Metric Medical Devices, Inc. with the FDA for Super Staple(tm) Classic.
Device ID | K123363 |
510k Number | K123363 |
Device Name: | SUPER STAPLE(TM) CLASSIC |
Classification | Staple, Fixation, Bone |
Applicant | METRIC MEDICAL DEVICES, INC. 846 SILVER SPRINGS Helotes, TX 78023 |
Contact | W Casey Fox Phd Pe |
Correspondent | W Casey Fox Phd Pe METRIC MEDICAL DEVICES, INC. 846 SILVER SPRINGS Helotes, TX 78023 |
Product Code | JDR |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-11-01 |
Decision Date | 2013-01-03 |
Summary: | summary |