510(k) K760723
K760723 is an FDA 510(k) premarket notification submitted by Parkell, Inc. for the device "SAFE-T-PINS RETENTIVE PIN SYSTEM". The FDA issued a decision of Substantially Equivalent on October 21, 1976. The device falls under product code EBL (Pin, Retentive And Splinting, And Accessory Instruments), a Class I device regulated under 21 CFR 872.3740. Parkell, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 21, 1976
- Date Received
- September 27, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pin, Retentive And Splinting, And Accessory Instruments
- Device Class
- Class I
- Regulation Number
- 872.3740
- Review Panel
- DE
- Submission Type