The following data is part of a premarket notification filed by Nashville Surgical Instruments with the FDA for Kumar T-anchors Hernia Set.
Device ID | K081366 |
510k Number | K081366 |
Device Name: | KUMAR T-ANCHORS HERNIA SET |
Classification | Suture, Nonabsorbable, Synthetic, Polyamide |
Applicant | NASHVILLE SURGICAL INSTRUMENTS 2005 KUMAR LANE Springfield, TN 37172 |
Contact | Sarbjeet Kumar |
Correspondent | Sarbjeet Kumar NASHVILLE SURGICAL INSTRUMENTS 2005 KUMAR LANE Springfield, TN 37172 |
Product Code | GAR |
CFR Regulation Number | 878.5020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-05-15 |
Decision Date | 2008-07-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B361TA0080 | K081366 | 000 |