510(k) K951623
K951623 is an FDA 510(k) premarket notification submitted by Tlc Tech Lab Clothes, Inc. for the device "TLC SURGICAL GOWNS". The FDA issued a decision of Substantially Equivalent on August 18, 1995. The device falls under product code FYA (Gown, Surgical), a Class II device regulated under 21 CFR 878.4040. Tlc Tech Lab Clothes, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 1995
- Date Received
- April 7, 1995
- 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