The following data is part of a premarket notification filed by Oxboro Medical Intl., Inc. with the FDA for Oxboro-medical Cautery Tip Cleaner.
| Device ID | K952784 |
| 510k Number | K952784 |
| Device Name: | OXBORO-MEDICAL CAUTERY TIP CLEANER |
| Classification | Unit, Cautery, Thermal, Battery-powered |
| 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 | HQP |
| CFR Regulation Number | 886.4115 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-19 |
| Decision Date | 1995-07-13 |