The following data is part of a premarket notification filed by Oxboro Medical Intl., Inc. with the FDA for Oxboro-medical Foam Instrument Holder.
| Device ID | K953068 |
| 510k Number | K953068 |
| Device Name: | OXBORO-MEDICAL FOAM INSTRUMENT HOLDER |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | OXBORO MEDICAL INTL., INC. 13828 LINCOLN ST. N.E. Ham Lake, MN 55304 |
| Contact | Harley Haade |
| Correspondent | Harley Haade OXBORO MEDICAL INTL., INC. 13828 LINCOLN ST. N.E. Ham Lake, MN 55304 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-30 |
| Decision Date | 1996-01-23 |