510(k) K894369
K894369 is an FDA 510(k) premarket notification submitted by Apdyne Medical Co. for the device "APDYNE PHENOL APPLICATOR KIT". The FDA issued a decision of Substantially Equivalent (with conditions) on October 12, 1989. The device falls under product code KCJ (Applicator, Ent), a Class I device regulated under 21 CFR 874.5220. Apdyne Medical Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- October 12, 1989
- Date Received
- July 14, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ent
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type