Product code LLK— General Hospital

FDA has cleared 4 devices under product code LLK between 1984 and 1990, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19901 clearance
• 19872 clearances
• 19841 clearance

• Tecnol New Jersey Wound Care, Inc.1 clearance
• Spacelabs, Inc.1 clearance
• Aci Medical, Inc.1 clearance
• A-T Surgical Mfg. Co., Inc.1 clearance

• K903532 — UNNA-SLEEVE(TM)Aci Medical, Inc.·1990-11-02
• K873368 — TECNOL COMPRESSION KNEE DRESSINGTecnol New Jersey Wound Care, Inc.·1987-12-11
• K871889 — COMPRESSION LEGGING DEVICEA-T Surgical Mfg. Co., Inc.·1987-08-04
• K834460 — MODEL 1888 ALPHA COS/RESPIRATION CARSpacelabs, Inc.·1984-02-13