510(k) K143068
- Device
- Medical Monofilament Sensory Screening Toool
- Applicant
- Medical Monofilament Manufacturing
- 510(k) number
- K143068
- Product code
- GXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-14
- Date received
- 2014-10-24
- Regulation
- 882.1500
- Classification name
- Esthesiometer
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Michelle Hardiman
- Address
- 121 Camelot Dr. Plymouth MA US 02360 02360
FDA Registration Numbers#
- 3013188547
- 2939821
- 1122845
- 3006795917
- 3007602302
- 3003348846
- 3013298431
- 3027555919
- 3010595915
- 3003974574
- 8040278
- 3014579161
- 3003993868
- 3016761372
- 3043226252
- 3015532217
- 3013143994
- 3001084743
- 3003533010
- 3042251628
- 3021275665
- 1226347
- 3004905643
- 3012494290
- 2432177
- 1058602
- 3007703436
- 1218386
- 3038624873
- 3004893971
- 3009308092
- 3004824601
- 3003771601
- 3011497622
- 3004526603
Source Documents#
Other 510(k) Records For Product Code GXB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K933798 | NU-PREP GEL | Cadwell Laboratories, Inc. | 1994-04-22 |
| K871571 | NEUROTIPS(TM) | Ulster Scientific, Inc. | 1987-06-18 |
| K801907 | ALGESIOMETER | Rowan Products, Inc. | 1980-09-16 |
| K772406 | AESTHESIOMETER | Fred Sammons, Inc. | 1978-01-06 |
| K771847 | TEMP-TESTER | Jablecki, Charles, Dr. | 1977-11-02 |
| K761133 | AESTHESIOMETER | Fred Sammons, Inc. | 1976-12-02 |
Legacy Summary#
summary
FDA Review#
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