FDA 510(k) Applications for Medical Device Product Code "HFW"
(Clamp, Umbilical)

FDA 510(k) Number Applicant Device Name Decision Date
K021055 BUSSE HOSPITAL DISPOSABLES, INC. BUSSE UMBILICAL CORD CLAMP CUTTER 04/29/2002
K010835 BUSSE HOSPITAL DISPOSABLES, INC. POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 04/30/2001
K012917 DYNAREX CORP. DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B 11/28/2001
K974227 GPS HOSPITAL'S CLAMP 12/12/1997
K983204 HARWILL MEDICAL (PTY) LTD. HARWILL MEDICAL U-KLIP UMBILICAL CLAMP 02/26/1999
K033846 KAEN YIH ENTERPRISE CO., LTD. KAEN YIH UMBILICAL CORD CLAMP 03/11/2004
K041332 MATERNUS, INC. JOEY CLAMP OPENING TOOL 06/25/2004
K010695 MATERNUS, INC. KOALA CLAMP 05/03/2001
K011621 MATERNUS, INC. KOALA CLAMP, KOALA CLAMP AND CUTTER 08/10/2001
K994367 MEDICAL SALES CO. UMBILICAL CORD CLAMP 03/17/2000
K963223 PHYLLIS ADAMS, RN, NPC, MSN EZ-CIRC 04/23/1997
K000227 POLLAK (INTL.), LTD. UMBICUT 04/27/2000
K990737 PRECISION DYNAMICS CORP. 'ECURLINE UMBILICAL CORD CLAMP #3500 04/06/1999
K020718 PRECISION DYNAMICS CORP. SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE 06/03/2002
K994263 PRECISION DYNAMICS CORP. SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540 01/24/2000
K963889 QFC INDUSTRIES QFC UMBILICAL CLAMP 04/18/1997
K963428 R.O.S.T. MEDICAL DEVELOPMENT, INC. UMBILICAL CLAMP AND CUTTER 04/01/1997


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