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 |