The following data is part of a premarket notification filed by Visionary Medical Supplies, Inc. with the FDA for Sutralene Polypropylene Sutures.
Device ID | K070243 |
510k Number | K070243 |
Device Name: | SUTRALENE POLYPROPYLENE SUTURES |
Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
Applicant | VISIONARY MEDICAL SUPPLIES, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
Contact | Gary Syring |
Correspondent | Gary Syring VISIONARY MEDICAL SUPPLIES, INC. 800 LEVANGER LN. Stoughton, WI 53589 |
Product Code | GAW |
CFR Regulation Number | 878.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-25 |
Decision Date | 2007-04-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
M583P990623 | K070243 | 000 |
M583P90090623 | K070243 | 000 |
M583P9006223 | K070243 | 000 |
M583P900623 | K070243 | 000 |
M583P90060623 | K070243 | 000 |
M583P540151RC3 | K070243 | 000 |
M583P109062TP3 | K070243 | 000 |
M583P1000623 | K070243 | 000 |