510(k) K894778
K894778 is an FDA 510(k) premarket notification submitted by Codman & Shurtleff, Inc. for the device "CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER". The FDA issued a decision of Substantially Equivalent on December 6, 1989. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150. Codman & Shurtleff, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 6, 1989
- Date Received
- July 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clip, Scalp
- Device Class
- Class II
- Regulation Number
- 882.4150
- Review Panel
- NE
- Submission Type