510(k) K994263
- Device
- SECURLINE UMBILICAL CORD CLAMP CLIPPER #3540
- Applicant
- PRECISION DYNAMICS CORP.
- 510(k) number
- K994263
- Product code
- HFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-01-24
- Date received
- 1999-12-17
- Regulation
- 884.4530
- Classification name
- Clamp, Umbilical
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KALYNA SNYLYK
- Address
- 13880 Del Sur St. San Fernando CA US 91340 91340
FDA Registration Numbers#
- 3003450039
- 3010339057
- 3013557562
- 9680254
- 1047429
- 3011137372
- 3016734145
- 3010221586
- 3004001706
- 3011524630
- 1417592
- 3043585890
- 1836161
- 9611024
- 3014579161
- 3008392711
- 3017635043
- 3007092328
- 9612086
- 3010041511
- 3008902714
- 1531062
- 2916714
- 2433012
- 3014421917
- 1450908
- 3019387954
- 3015173212
- 3006554788
- 3030446844
- 1030451
- 3042970965
- 3035642068
- 3018071447
- 3008489813
- 3016426851
- 3004519921
- 3013683058
- 3012494290
- 3010055973
- 3013576541
- 1422634
- 3014926389
- 3014314985
- 3015060216
- 3005695838
- 3013497020
- 3006897996
- 3030733800
- 9610612
- 3005273623
Source Documents#
Other 510(k) Records For Product Code HFW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041332 | JOEY CLAMP OPENING TOOL | Maternus, Inc. | 2004-06-25 |
| K033846 | KAEN YIH UMBILICAL CORD CLAMP | Kaen Yih Enterprise Co., Ltd. | 2004-03-11 |
| K020718 | SECURLINE UMBILICAL CORD CLAMP #3505 STERILE #3515 NON-STERILE | Precision Dynamics Corp. | 2002-06-03 |
| K021055 | BUSSE UMBILICAL CORD CLAMP CUTTER | Busse Hospital Disposables, Inc. | 2002-04-29 |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Dynarex Corp. | 2001-11-28 |
| K011621 | KOALA CLAMP, KOALA CLAMP AND CUTTER | Maternus, Inc. | 2001-08-10 |
| K010695 | KOALA CLAMP | Maternus, Inc. | 2001-05-03 |
| K010835 | POSI-GRIP UMBILICAL CORD CLAMP, STERILE, MODEL 384, POSI-GRIP UMBILICAL CORD CLAMP, NON-STERILE, MODEL 385 | Busse Hospital Disposables, Inc. | 2001-04-30 |
| K000227 | UMBICUT | Pollak (Intl.), Ltd. | 2000-04-27 |
| K994367 | UMBILICAL CORD CLAMP | Medical Sales Co. | 2000-03-17 |
| K990737 | 'ECURLINE UMBILICAL CORD CLAMP #3500 | Precision Dynamics Corp. | 1999-04-06 |
| K983204 | HARWILL MEDICAL U-KLIP UMBILICAL CLAMP | Harwill Medical (Pty) , Ltd. | 1999-02-26 |
| K974227 | HOSPITAL'S CLAMP | Gps | 1997-12-12 |
| K963223 | EZ-CIRC | Phyllis Adams, Rn, Npc, Msn | 1997-04-23 |
| K963889 | QFC UMBILICAL CLAMP | Qfc Industries | 1997-04-18 |
Legacy Summary#
summary
FDA Review#
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