510(k) K864019
- Device
- NEEDLE NOSE PLIERS
- Applicant
- MED-TOOL, INC.
- 510(k) number
- K864019
- Product code
- HTC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-30
- Date received
- 1986-10-15
- Regulation
- 878.4800
- Classification name
- Pliers, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- MAYERIK, JR.
- Address
- 12434 Matthews Ln. St. Louis MO US 63127 63127
FDA Registration Numbers#
- 3006059835
- 3044819802
- 1057946
- 1935627
- 3003759558
- 8010252
- 1032347
- 9710524
- 3004464325
- 8040263
- 3011567699
- 3009468807
- 3011365613
- 8010234
- 8010769
- 1226544
- 3007648354
- 3012226300
- 3039414397
- 3008812560
- 1828464
- 8040233
- 3015895045
- 3012086398
- 3009158523
- 3027556548
- 2085199
- 9616246
- 1043534
- 1421101
- 8010591
- 9610809
- 3005031160
- 3010331645
- 3005273623
- 3019404837
- 1030489
- 9680260
- 3031564283
- 3008770252
- 3002769835
- 3006801265
- 3007773213
- 9680619
- 1833053
- 3003877407
- 3009340886
- 3006554912
- 1058726
- 3019269298
- 3003905396
- 1836161
- 2183570
- 3005587147
- 1834179
- 3038776593
- 1818910
- 3004892425
- 3003956316
- 9610612
- 1417592
- 8010935
- 3008902714
- 3011371465
- 3010829427
- 3015212339
- 3038195984
- 8030607
- 3016050940
- 3015882686
- 3003418325
- 3036795921
- 3010687973
- 1056350
- 9614062
- 9680515
- 1422507
- 3005809810
- 8040278
- 3014334038
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HTC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872384 | SIDE CUTTING PARALLEL ACTION PLIERS | Med-Tool, Inc. | 1987-07-02 |
| K861953 | PARALLEL ACTION PLIERS | Med-Tool, Inc. | 1986-06-06 |
| K854390 | WIRE CUTTING PLIERS OR LINEMAN'S PLIERS | Med-Tool, Inc. | 1985-11-19 |
| K844600 | SLIP JOINT PLIERS | Med-Tool, Inc. | 1984-12-14 |
| K844146 | TOGGLE LOCKING PLIERS-STRAIGHT JAW, CURVED JAW | Med-Tool, Inc. | 1984-11-20 |
| K840978 | TOGGLE LOCKING PLIER | Med-Tool, Inc. | 1984-04-25 |
| K840979 | SLIP JOINT PLIER | Med-Tool, Inc. | 1984-04-25 |
| K840980 | HALF ROUND FILE | Med-Tool, Inc. | 1984-04-25 |
| K830721 | WIRE TWISTERS | The Anspach Effort, Inc. | 1983-04-12 |
Legacy Summary#
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FDA Review#
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