510(k) K875129
- Device
- STERI-CLENS
- Applicant
- ABSORBENT COTTON CO., INC.
- 510(k) number
- K875129
- Product code
- GEC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-18
- Date received
- 1987-12-15
- Regulation
- 878.4800
- Classification name
- Brush, Scrub, Operating-room
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PATRICK J LAMB
- Address
- P.O. Box 268 368 Fairview Ave. Hammonton NJ US 08037 08037
FDA Registration Numbers#
- 3010131137
- 3010656982
- 3010248787
- 3015821396
- 9616088
- 3018159714
- 1061124
- 1032347
- 3012599928
- 3031184338
- 3045058049
- 3027234828
- 3002806603
- 2243072
- 9680488
- 9681465
- 3011137372
- 3007113238
- 3006891803
- 3008824097
- 3015058854
- 3011983031
- 3006536657
- 3030516433
- 2648727
- 3001124136
- 3038718579
- 9710020
- 3014314985
- 3024860669
- 1250045
- 3015337373
- 3018762668
- 2011171
- 3016970619
- 3034669683
- 3015895045
- 2027062
- 1054811
- 3017178443
- 3015140351
- 3034629649
- 1417592
- 3004878380
- 3007007790
- 3004340271
- 3004425647
- 3014926389
- 3000268902
- 3011237770
- 3012660022
- 2032112
- 9612030
- 3010667733
- 3013517171
- 3013557562
- 9613910
- 1211177
- 3015745029
- 9710567
- 3010041511
- 1928237
- 8040278
- 9710524
- 3009104075
- 3006210673
- 1836161
- 9611367
- 3005327291
- 3038187464
- 3014437893
- 2029015
- 3007344957
- 3004941127
- 3008384335
- 1421879
- 1920898
- 3038276119
- 3015140199
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971473 | IVALON INSTRUMENT WIPE, IVALON KNIFE CLEANING BLOCK | M-Pact Worldwide Management Corp. | 1997-07-07 |
| K960621 | EXPANDACELL INSTRUMENT WIPE | Shippert Medical Technologies Corp. | 1996-04-01 |
| K900691 | BIODYNE INSTRUMENT WIPES | Bio-Dyne, Inc. | 1990-03-08 |
| K896085 | SURGI-BRUSH | Sparta Surgical Corp. | 1989-11-08 |
| K875033 | STERILE SCRUBBY SCRUB BRUSH | Medsurg Industries, Inc. | 1988-02-19 |
| K872823 | DELTA SCRUB | Pacific Biosystems, Inc. | 1988-01-07 |
| K874653 | STERILE SURGICAL SCRUB BRUSH | Surgikos, Inc. | 1987-12-30 |
| K874741 | STERI-CLENS(TM) SURGICAL SCRUB SPONGE | Absorbent Cotton Co., Inc. | 1987-12-10 |
| K870258 | BIOSCRUB SURGICAL SCRUB BRUSH | K. W. Griffen Co. | 1987-02-24 |
| K854232 | PHARMASEAL SCRUB CARE-SURGICAL SCRUB BRUSH SPONGES | American Pharmaseal Div. Ahsc | 1985-12-10 |
| K844411 | SCRUB MATE DRY STERILE SCRUB BRUSH | American Sterilizer Co. | 1984-12-17 |
| K843636 | FOAM CARE ONE STEP PREP | Ballard Medical Products | 1984-11-16 |
| K831488 | DAVRON PROF. SCRUB BRUSH-DRY/STERILE | Minnetonka, Inc. | 1983-06-08 |
| K831226 | MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450 | Ballard Medical Products | 1983-05-16 |
| K830394 | PROVIDONE-IODINE PREP-PADS & TOWELETTES | H & P Industries, Inc. | 1983-04-06 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases