Product code HMW— General, Plastic Surgery

FDA has cleared 4 devices under product code HMW between 1984 and 1991, 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.

• 19911 clearance
• 19902 clearances
• 19841 clearance

• North American Sterilization & Packaging Co.1 clearance
• Medical Technique Instruments, Inc.1 clearance
• Lifestream Int'L, Inc.1 clearance
• Invotec International, Inc.1 clearance

• K911040 — INVOTEC MICROSCOPE DRAPEInvotec International, Inc.·1991-06-03
• K902763 — STERILE INSTRUMENT DRAPENorth American Sterilization & Packaging Co.·1990-09-20
• K902851 — MICROSCOPE DRAPEMedical Technique Instruments, Inc.·1990-09-10
• K843890 — CUSTOM INSTRUMENT DRAPELifestream Int'L, Inc.·1984-10-26