510(k) K881265
K881265 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "RANEY CLIPS". The FDA issued a decision of Substantially Equivalent on May 31, 1988. The device falls under product code HBO (Clip, Scalp), a Class II device regulated under 21 CFR 882.4150. Zimmer, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 1988
- Date Received
- March 24, 1988
- 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