510(k) K780613
- Device
- Enema, Phosphate
- Applicant
- ABCO DEALERS, INC.
- 510(k) number
- K780613
- Product code
- FCE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-06-02
- Date received
- 1978-04-10
- Regulation
- 876.5210
- Classification name
- Enema Kit
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- 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#
- 3014686987
- 3014615175
- 3015173212
- 1423537
- 3015821396
- 3043619925
- 3005669815
- 3009888344
- 9611665
- 1530671
- 3006553489
- 3014828281
- 8010730
- 2648727
- 3034669683
- 3017896419
- 2183416
- 3007007790
- 3009349165
- 3007289408
- 1921846
- 1043646
- 3014637079
- 3006542501
- 3016171914
- 3016685983
- 3010409218
- 3014326210
- 3006131984
- 3012110942
- 3016255836
- 3026848699
- 1050589
- 3012568936
- 3011209790
- 3004111573
- 3009632672
- 3011919098
- 3016585381
- 3015058854
- 3013395518
- 3011489270
- 1420054
- 3038700860
- 3012002722
- 3006673317
- 3006606901
- 9613910
- 1643817
- 9610694
- 3008009450
- 3010131137
- 3014122529
- 2320961
- 3008502431
- 9710641
- 3018762668
- 1480288
- 9612030
- 1061124
- 9616083
- 3014195785
- 1928237
- 3005273623
- 3013846070
- 3004472854
- 3015337348
- 3004122598
- 3020777598
- 8040278
- 1526863
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FCE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974042 | AMSURE CLEANSING ENEMA SET | Amsino Intl., Inc. | 1997-12-19 |
| K931896 | PRO-FLO SYSTEM | Lafayette Pharmacal, Inc. | 1993-08-26 |
| K922398 | 4 SURE TM ENEMA BAG SET | Boston Pacific Medical, Inc. | 1993-06-17 |
| K913620 | ENEMA KIT | York County Blind Center | 1991-11-01 |
| K904534 | ENEMA BULB | R.A.C., Inc. | 1990-12-21 |
| K901182 | ENEMA BAG SET | Orion Life Systems, Inc. | 1990-06-28 |
| K901179 | ENEMA BUCKET SET | Orion Life Systems, Inc. | 1990-06-28 |
| K900848 | ENEMA KIT 'STRAIGHT' DESIGN | Custom Medical Products, Ltd. | 1990-04-13 |
| K900847 | ENEMA KIT 'Y' DESIGN | Custom Medical Products, Ltd. | 1990-04-13 |
| K881218 | GENT-L-KARE CLEANSING ENEMA SET | Geneva Laboratories, Inc. | 1988-07-28 |
| K880337 | MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700 | Plasco, Inc. | 1988-04-14 |
| K872992 | SPS SUSPENSION ENEMA KIT | Carolina Medical Products Co. | 1987-09-17 |
| K870796 | MACBICK-XL BASIC AIR CONTAST BARIUM ENEMA DELIV SY | Plasco, Inc. | 1987-04-01 |
| K870019 | THE LAHR BALLOON | Plasco, Inc. | 1987-04-01 |
| K843792 | VAN JON SUPER CLYSTER(KIT, ENEMA | Van Jon Co. | 1985-04-22 |