510(k) K871889
K871889 is an FDA 510(k) premarket notification submitted by A-T Surgical Mfg. Co., Inc. for the device "COMPRESSION LEGGING DEVICE". The FDA issued a decision of Substantially Equivalent on August 4, 1987. The device falls under product code LLK (Legging, Compression, Non-Inflatable), a Class II device regulated under 21 CFR 880.5780. A-T Surgical Mfg. Co., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1987
- Date Received
- May 15, 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