510(k) K870136
- Device
- Personal Punch
- Applicant
- ARNOLD TECHNOLOGIES
- 510(k) number
- K870136
- Product code
- EXB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-04-01
- Date received
- 1987-01-13
- Regulation
- 876.5900
- Classification name
- Collector, Ostomy
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAN ARNOLD
- Address
- 1420 Sumter St. Leesburg FL US 32748 32748
FDA Registration Numbers#
- 9617198
- 1423537
- 3011987967
- 9616668
- 3013863160
- 3016615875
- 3043106340
- 3027514586
- 3031582434
- 1119193
- 1047843
- 9616088
- 3022959562
- 2530957
- 1018233
- 3043041723
- 3006580788
- 3010683450
- 3011689956
- 3011307048
- 3015332213
- 3011707784
- 1835573
- 3042024502
- 3038718579
- 9611590
- 3004111573
- 1825146
- 3008806809
- 1643817
- 3003814961
- 3012465068
- 3008244559
- 1820334
- 3015140210
- 1061124
- 3016678045
- 3005945907
- 3009888344
- 3015131144
- 3006371704
- 3030733800
- 3011495142
- 3014016843
- 3015140199
- 3013530901
- 3013298431
- 1424263
- 3006131984
- 1000317571
- 3001124136
- 9618003
- 3025585194
- 3005941719
- 9610694
- 3030398124
- 2320961
- 3006082230
- 9710641
- 3012494290
- 1480288
- 3017533431
- 3030087693
- 2417346
- 3016872092
- 3022320425
- 3008262278
- 3006405073
- 1450662
- 3009167225
- 3030446844
- 3016675012
- 3010543854
- 3015142802
- 3018116884
- 3014579161
- 3018077255
- 3016785268
- 3033967997
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EXB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252140 | Heylo™ System | Coloplast Corp. | 2025-10-06 |
| K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | 2018-11-16 |
| K140938 | OSTOM-I ALERT | 11 Health and Technologies, LLC | 2014-10-10 |
| K922730 | LAKE OSTOMY CARE SET | Lake Medical Products, Inc. | 1993-12-30 |
| K882878 | ODOR-END EMERGENCY CLEAN UP POWDER | Cdc Products Corp. | 1988-12-08 |
| K881636 | CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE) | Coloplast A/S | 1988-07-13 |
| K880306 | EMERGENCY-CLEAN UP(TM) ECP | Cdc Products Corp. | 1988-05-20 |
| K872294 | COMBINATION NITE DRAINAGE UNIT | Arnold Technologies | 1987-12-29 |
| K873929 | 'CATCH-IT' OR FECAL CONTAINMENT DEVICE | Midwest Medical Co. | 1987-12-03 |
| K871526 | ODOR-SAFE(TM)(LIQUID) ODOR-SAFE(TM) POWDER | Cox Family Laboratories, Inc. | 1987-10-13 |
| K871738 | OSTO-PURE | Clearchem Corp. | 1987-08-12 |
| K871628 | PALEX (R) OSTOMY | Industrias Palex C/O Dma Med-Chem Corp. | 1987-07-08 |
| K870577 | E-Z LOOP | John F. Greer Co., Inc. | 1987-04-17 |
| K870531 | EZ TAC FILTER | John F. Greer Co., Inc. | 1987-04-10 |
| K864189 | ULTRA-GEL - #4083 | John F. Greer Co., Inc. | 1986-12-04 |