The following data is part of a premarket notification filed by Oxboro Medical Intl., Inc. with the FDA for Omed Wound Closure Strips.
Device ID | K874813 |
510k Number | K874813 |
Device Name: | OMED WOUND CLOSURE STRIPS |
Classification | Strip, Adhesive, Closure, Skin |
Applicant | OXBORO MEDICAL INTL., INC. 9635 GIRARD AVE SOUTH Bloomington, MN 55431 |
Contact | Kevin P Maxwell |
Correspondent | Kevin P Maxwell OXBORO MEDICAL INTL., INC. 9635 GIRARD AVE SOUTH Bloomington, MN 55431 |
Product Code | FPX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-24 |
Decision Date | 1988-01-29 |