510(k) K925215
K925215 is an FDA 510(k) premarket notification submitted by American Healthcare Supply Co., Inc. for the device "STERILE SURGICAL INSTRUMENT TRAYS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 1, 1993. The device falls under product code KDD (Kit, Surgical Instrument, Disposable), a Class I device regulated under 21 CFR 878.4800. American Healthcare Supply Co., Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- June 1, 1993
- Date Received
- October 16, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Surgical Instrument, Disposable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type