The following data is part of a premarket notification filed by Medical Surgical, Inc. with the FDA for Med-surg Suture Washer.
Device ID | K950250 |
510k Number | K950250 |
Device Name: | MED-SURG SUTURE WASHER |
Classification | Screw, Fixation, Bone |
Applicant | MEDICAL SURGICAL, INC. 5924 7TH ST., N.E. Minneapolis, MN 55432 |
Contact | James Knoepfle |
Correspondent | James Knoepfle MEDICAL SURGICAL, INC. 5924 7TH ST., N.E. Minneapolis, MN 55432 |
Product Code | HWC |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-23 |
Decision Date | 1995-05-17 |