The following data is part of a premarket notification filed by Oxboro Medical Intl., Inc. with the FDA for Oxboro-medical Pin Covers.
Device ID | K952783 |
510k Number | K952783 |
Device Name: | OXBORO-MEDICAL PIN COVERS |
Classification | Wire, Surgical |
Applicant | OXBORO MEDICAL INTL., INC. 13828 LINCOLN ST. N.E. Ham Lake, MN 55304 |
Contact | Harley Haase |
Correspondent | Harley Haase OXBORO MEDICAL INTL., INC. 13828 LINCOLN ST. N.E. Ham Lake, MN 55304 |
Product Code | LRN |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-19 |
Decision Date | 1995-09-15 |