510(k) K873368
K873368 is an FDA 510(k) premarket notification submitted by Tecnol New Jersey Wound Care, Inc. for the device "TECNOL COMPRESSION KNEE DRESSING". The FDA issued a decision of Substantially Equivalent on December 11, 1987. The device falls under product code LLK (Legging, Compression, Non-Inflatable), a Class II device regulated under 21 CFR 880.5780. Tecnol New Jersey Wound Care, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 11, 1987
- Date Received
- August 21, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Legging, Compression, Non-Inflatable
- Device Class
- Class II
- Regulation Number
- 880.5780
- Review Panel
- HO
- Submission Type