The following data is part of a premarket notification filed by Apdyne Medical Co. with the FDA for Apdyne Phenol Applicator Kit.
| Device ID | K894369 |
| 510k Number | K894369 |
| Device Name: | APDYNE PHENOL APPLICATOR KIT |
| Classification | Applicator, Ent |
| Applicant | APDYNE MEDICAL CO. 955 WEST IDAHO AVE. Saint Paul, MN 55117 |
| Contact | Michael W Walsh |
| Correspondent | Michael W Walsh APDYNE MEDICAL CO. 955 WEST IDAHO AVE. Saint Paul, MN 55117 |
| Product Code | KCJ |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-14 |
| Decision Date | 1989-10-12 |