510(k) K970694
- Device
- MODEL 1700, HYDRO PREP
- Applicant
- PHYSIOMETRIX, INC.
- 510(k) number
- K970694
- Product code
- HBA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-05-14
- Date received
- 1997-02-25
- Regulation
- 882.4700
- Classification name
- Neurosurgical Paddie
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAWN E FRAZER
- Address
- Five Billerica Park, 101 Billerica Ave. North Billerica MA US 01862 01862
FDA Registration Numbers#
- 3031757047
- 1528161
- 3004146401
- 1417592
- 2011115
- 3007481893
- 1650946
- 3011310592
- 3016852448
- 3013957847
- 9611252
- 9611558
- 3027329006
- 3031841433
- 3006626283
- 9613619
- 1718791
- 3010097863
- 3012494290
- 2080783
- 3012386142
- 3010515191
- 3006551156
- 3042272797
- 3008085016
- 2245302
- 3010836847
- 3003676119
- 3042268484
- 3043013796
- 3006459199
- 1000524645
- 3001236514
- 3011534533
- 3011077581
- 1626185
- 3031464228
- 3011721071
- 3036720861
- 3013917867
- 2212018
- 3006315274
- 3014236293
- 8030229
- 3006982887
- 3017953405
- 3028172072
- 3012316249
- 9710580
- 1000150986
- 3006258337
- 3023339103
- 1055808
- 3013501110
- 1017294
- 3028011
Source Documents#
Other 510(k) Records For Product Code HBA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K193346 | Codman Surgical Patties & Strips | Integra LifeSciences Corporation | 2020-11-20 |
| K140369 | MEDLINE NEURO SPONGE | Medline Industries, Inc. | 2014-09-26 |
| K112598 | AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND) | American Surgical Company, LLC | 2013-06-20 |
| K121822 | DELICOT | American Surgical Company, LLC | 2012-09-10 |
| K073576 | NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES | Harod Enterprises, Inc. | 2008-02-22 |
| K062406 | AESCULAP NEURO PATTIES | Aesculap, Inc. | 2006-09-15 |
| K031008 | AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE) | Aesculap | 2003-05-09 |
| K020736 | TRAATEK COTTONOID PATTIES | Traatek, Inc. | 2002-06-03 |
| K014268 | NORAPAD PLAIN; NORAPAD TA | Perlei Medical, Inc. | 2002-03-27 |
| K993019 | PACIFIC SURGICAL PATTIES | V. Mueller Neuro/Spine | 2000-03-30 |
| K973083 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1997-12-09 |
| K962807 | AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES | American Surgical Sponges | 1997-05-02 |
| K970328 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1997-04-21 |
| K950647 | ULTRACELL NEURO SPONGES | Ultracell Medical Technologies, Inc. | 1995-08-15 |
| K914600 | NEUROLOGICAL SPONGE | I M, Inc. | 1992-12-30 |
Legacy Summary#
summary
FDA Review#
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