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#
- 3005677016
- 3023657851
- 3030644259
- 3038718579
- 3005440795
- 9616671
- 3007507973
- 8010372
- 8010591
- 3004215117
- 2249529
- 2431166
- 2087382
- 3006059835
- 1421879
- 1056350
- 3004892425
- 8040278
- 3012101664
- 3002090132
- 3010041511
- 3035678069
- 1923569
- 3010687973
- 1020279
- 9611827
- 3006487092
- 8010769
- 2183449
- 9611579
- 3015212339
- 3008338766
- 8040263
- 9611283
- 1833824
- 1833053
- 3005031160
- 3007597038
- 3004598675
- 1226544
- 3013011598
- 3002976036
- 3003759558
- 1822565
- 3010699884
- 3009340886
- 3015895045
- 3014207283
- 1030489
- 8031015
- 8031020
- 3008808049
- 3005273623
- 3010898856
- 8010697
- 3001297506
- 3027556548
- 3011567699
- 3002675176
- 1032347
- 3002761766
- 3005587147
- 3014680795
- 3027404764
- 3003526896
- 3012725451
- 3002769844
- 3013946322
- 3006128100
- 3013358456
- 3004001706
- 3006801265
- 3010667733
- 3010097171
- 1836161
- 3008455034
- 3038776593
- 8010935
- 3009468807
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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