510(k) K822372
K822372 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "OFFICE ECONO-FORCEPS". The FDA issued a decision of Substantially Equivalent on Sep 9, 1982. The device falls under product code KAE (Forceps, Ent), a Class I device regulated under 21 CFR 874.4420. Treace Medical, Inc. has 79 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 9, 1982
- Date Received
- Aug 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Forceps, Ent
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type
- 510(k) Exempt