510(k) K772298
- Device
- SEXUAL ASSAULT FORENCIC EVIDENCE KIT
- Applicant
- SIMPSON/BASYE, INC.
- 510(k) number
- K772298
- Product code
- KXF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-03-02
- Date received
- 1977-12-13
- Regulation
- 880.6025
- Classification name
- Applicator, Absorbent Tipped, Non-sterile
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3017299798
- 2020550
- 3008386507
- 9616250
- 3034669683
- 8041151
- 3004305946
- 3010864832
- 3016824824
- 3009420946
- 3008729549
- 9710020
- 3004118636
- 3011676045
- 8030647
- 3010374972
- 3014159736
- 3016509759
- 3015531959
- 9613926
- 3027320022
- 2523320
- 3013473968
- 3013600135
- 3004753358
- 3007187674
- 3042024535
- 3006639700
- 3010595767
- 3005558160
- 3011632
- 3042367543
- 1054241
- 3011669217
- 3038274448
- 3010583458
- 3006629593
- 1419181
- 3012041047
- 3014325803
- 3003887292
- 9616872
- 3031184338
- 2083595
- 3016159368
- 8043816
- 3016763307
- 3008195902
- 3045857302
- 3011434305
- 3006536571
- 3027605322
- 1224960
- 3010339057
- 3012421607
- 3007305426
- 3014146451
- 3015378469
- 3009511130
- 1250045
- 3013632692
- 3014926389
- 3027242412
- 3038276119
- 3019912897
- 3008676146
- 3013547614
- 2916714
- 3004111573
- 3015505238
- 3008076203
- 3042278984
- 3028725772
- 3007143236
- 3030795695
- 3008355340
- 8043685
- 3016861904
- 3006450239
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KXF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K123184 | FINN CHAMBERS AQUA | Smartpractice | 2012-12-19 |
| K103409 | ALLERGEAZE R CLEAR | Smartpractice | 2011-03-15 |
| K063160 | ALLERGEAZE PATCH TEST CHAMBERS | Smartpractice | 2006-12-22 |
| K013820 | FINN CHAMBER (R) | Epitest Ltd. OY | 2002-01-30 |
| K992553 | IQ CHAMBERS | Dormer Laboratories, Inc. | 2000-04-12 |
| K870762 | EAR APPLICATOR, CATALOG NO. 2229 | Treace Medical, Inc. | 1987-03-06 |
| K843720 | COTTON TIPPED APPLICATORS, SINGLE | Abco Dealers, Inc. | 1984-10-04 |
| K820962 | COTTON SWABS | Dafoe & Dafoe, Inc. | 1982-04-20 |
| K813506 | FARRORS TMJ CASSETTE HOLDER | Brell Mar Products, Inc. | 1982-01-29 |
| K811365 | HILL TOP CHAMBER | Hill Top Research, Inc. | 1981-08-20 |
| K802580 | SUBCLAVIAN CATHETER INSERTION TRAY | American Pharmaseal Div. Ahsc | 1980-11-12 |
| K802016 | EYE APPLICATORS CAT.#980-983 | Pollak (Intl.), Ltd. | 1980-09-16 |
| K802020 | PREP SET CAT.#908 | Pollak (Intl.), Ltd. | 1980-09-09 |
| K791168 | DEXIDE DISPOSABLE PREP STICK | Dexide, Inc. | 1979-07-30 |
| K791169 | DEXIDE DISPOSABLE SWAB STICK | Dexide, Inc. | 1979-07-30 |
Legacy Summary#
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FDA Review#
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