510(k) K864190
- Device
- E-Z HOLD - #4060
- Applicant
- JOHN F. GREER CO., INC.
- 510(k) number
- K864190
- Product code
- KMK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-01-14
- Date received
- 1986-10-27
- Regulation
- 880.5210
- Classification name
- Device, Intravascular Catheter Securement
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LELAND H GREER
- Address
- 530 E. 12th St. Oakland CA US 94606 94606
FDA Registration Numbers#
- 1000563940
- 3036933864
- 3025337868
- 9616088
- 3031841433
- 3022596459
- 3042903214
- 3003974574
- 3032911850
- 1319454
- 3011987967
- 1018470
- 3003152976
- 3015335956
- 3008255748
- 1000374440
- 3017636737
- 3013122778
- 3031184338
- 3012543139
- 3015309643
- 1219313
- 3030733800
- 3007207474
- 8030941
- 2183744
- 1054811
- 9680271
- 9610825
- 3020976354
- 3043496870
- 3013557562
- 3016674858
- 3007407626
- 3012798826
- 1018233
- 9611590
- 3011642792
- 3010395155
- 1931876
- 3010041511
- 3015173212
- 3010824458
- 3015225571
- 1423537
- 9616791
- 2523676
- 3033891906
- 3044707998
- 9680091
- 3015859709
- 8030607
- 3003835287
- 2025917
- 1928237
- 1721676
- 1417592
- 1649914
- 3011137372
- 3011237770
- 3003767891
- 2521402
- 3013613028
- 3004111573
- 1043214
- 2518902
- 3045857302
- 3031564213
- 3009655869
- 3001576493
- 1223925
- 3003636207
- 3045058049
- 3012706495
- 3009600453
- 3006425876
- 3016863553
- 2029275
- 3042840696
- 3012494290
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KMK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | Interrad Medical, Inc. | 2019-07-09 |
| K981860 | A P HARNESS | Paraworks Enterprise, Ltd. | 1999-06-03 |
| K963365 | MULTI-PURPOSE MEDICAL TUBE HOLDER | Byrd Medical Devices, Inc. | 1996-10-11 |
| K941098 | SECURE-SITE | Op-Co Medical Products , Ltd. | 1995-08-09 |
| K943147 | STATLOCK CV | Venetec, Inc. | 1994-09-29 |
| K943047 | IV START KITS | Sterile Concepts, Inc. | 1994-09-14 |
| K941850 | IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE | Tnt Moborg Intl. , Ltd. | 1994-07-14 |
| K941940 | IMMOBILE STERILE AND IMMOBILE A/C STERILE | Tnt Moborg Intl. , Ltd. | 1994-07-14 |
| K935389 | CONMED VENI-GARD I.V. DRESSING | Conmedcorp | 1994-03-07 |
| K935252 | K-LOK CATHETER SECUREMENT DEVICE MODIFICATION | K-Lok, Inc. | 1994-02-18 |
| K940127 | CENTERMARK SECURING WINGS | Menlo Care, Inc. | 1994-02-09 |
| K932757 | SECURODRIP (TM) I.V. ARMBOARD | Op-Co Medical Products , Ltd. | 1993-12-08 |
| K925992 | DUODERM TRANSPARENT HYDROCOLLOID DRESSING | Convatec, A Division of E.R. Squibb & Sons | 1993-10-15 |
| K930663 | IV COMFORT PAD | D.J. Scott Mfg., Inc. | 1993-09-30 |
| K922103 | IAB ANCHOR | Datascope Corp. | 1993-08-03 |
Legacy Summary#
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FDA Review#
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