510(k) K874741
- Device
- STERI-CLENS(TM) SURGICAL SCRUB SPONGE
- Applicant
- ABSORBENT COTTON CO., INC.
- 510(k) number
- K874741
- Product code
- GEC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-12-10
- Date received
- 1987-11-23
- 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#
- 3004941127
- 3015895045
- 3006260740
- 3015337373
- 3001124136
- 8022032
- 3003965134
- 1421879
- 1835572
- 3007007790
- 3034629649
- 9611827
- 3013557562
- 3038276119
- 1048735
- 3002806603
- 3005327291
- 3009104075
- 3003418325
- 1420054
- 3019455
- 1211177
- 8040278
- 3018762668
- 1423507
- 9611367
- 2011171
- 3007517215
- 3018159714
- 2029015
- 1043534
- 3014437893
- 1054811
- 9681465
- 9710567
- 1032347
- 1928237
- 3008770252
- 3008384335
- 3007113238
- 1710034
- 3009403363
- 1061124
- 1921846
- 3016159368
- 9710020
- 3003807268
- 3008489813
- 3010667733
- 3015821396
- 3012599928
- 3004569180
- 3004878380
- 3004111573
- 3045526618
- 3013517171
- 3014314985
- 3045742729
- 3038187464
- 2648727
- 9710524
- 3004425647
- 3007597038
- 3015745029
- 3010041511
- 3005012805
- 3015416207
- 2027062
- 3018503755
- 1000443955
- 9680488
- 3012821559
- 2431166
- 3006891803
- 3011137372
- 2086043
- 1920898
- 3015139841
- 3010656982
- 3034669683
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 |
| K875129 | STERI-CLENS | Absorbent Cotton Co., Inc. | 1988-02-18 |
| K872823 | DELTA SCRUB | Pacific Biosystems, Inc. | 1988-01-07 |
| K874653 | STERILE SURGICAL SCRUB BRUSH | Surgikos, Inc. | 1987-12-30 |
| 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 |
| K830393 | PROVIDONE-IODINE SWABSTICKS | 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