510(k) K012268
K012268 is an FDA 510(k) premarket notification submitted by Standard Textile Co., Inc. for the device "TRIMAX". The FDA issued a decision of Substantially Equivalent on Dec 3, 2001. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Standard Textile Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 3, 2001
- Date Received
- Jul 19, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gown, Surgical
- Device Class
- Class II
- Regulation Number
- 878.4040
- Review Panel
- HO
- Submission Type