510(k) K770583
- Device
- MEDI-PAK LEMON GLYCEOIN SWABS
- Applicant
- General Medical Co.
- 510(k) number
- K770583
- Product code
- KXF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-05-26
- Date received
- 1977-03-28
- 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
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006487092
- 3008195902
- 1423537
- 3011713204
- 3006538822
- 3004753334
- 3034669683
- 3038632739
- 3010147274
- 3006795767
- 3017417635
- 3036679730
- 3008381300
- 3005816808
- 3011194487
- 3034531746
- 3016509759
- 1054241
- 3008687634
- 3038274448
- 3008770655
- 3005558160
- 3009443653
- 9611959
- 3016267994
- 1220477
- 1121142
- 9680836
- 3025413691
- 3023339277
- 3008386507
- 3003361112
- 2938386
- 3010864832
- 3006852457
- 3017434950
- 3044466317
- 3015416207
- 3030528528
- 3012309743
- 3021386681
- 3011205500
- 3019912897
- 9611367
- 3004911384
- 1061124
- 3013463240
- 3017079526
- 3006608997
- 3009155756
- 3017751928
- 2320762
- 3003902419
- 2916714
- 3007517215
- 3008559238
- 3015745029
- 3010598169
- 3017609565
- 3012041047
- 3017910185
- 3008808560
- 3008044484
- 3008355340
- 3008496560
- 3004727093
- 2183301
- 3014325803
- 8010099
- 3015505238
- 3009290468
- 3031184338
- 8040233
- 3008384335
- 3008676146
- 3004595864
- 3011270181
- 9613926
- 3007305426
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 |