510(k) K923408
K923408 is an FDA 510(k) premarket notification submitted by Standard Textile Co., Inc. for the device "WRAPPEL T". The FDA issued a decision of Substantially Equivalent on April 8, 1993. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Standard Textile Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1993
- Date Received
- July 10, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wrap, Sterilization
- Device Class
- Class II
- Regulation Number
- 880.6850
- Review Panel
- HO
- Submission Type