510(k) K871535
K871535 is an FDA 510(k) premarket notification submitted by Link America, Inc. for the device "SMILJANIC BONE REPOSITIONING FORCEPS". The FDA issued a decision of Substantially Equivalent on May 14, 1987. The device falls under product code HTD (Forceps), a Class I device regulated under 21 CFR 878.4800. Link America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 1987
- Date Received
- April 20, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type