MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700
FDA 510(k) clearance K880337 · decided 1988-04-14
Clearance details
- K-number
- K880337
- Device name
- MACBICK DISPOSABLE BARIUM ENEMA SYST 4800 & 4700
- Applicant
- Plasco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-01-26
- Decision date
- 1988-04-14
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- FCE
- Device class
- 1
- Regulation number
- 876.5210
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gurnee, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMSURE CLEANSING ENEMA SET (K974042) | Amsino Intl., Inc. | 1997-12-19 |
| PRO-FLO SYSTEM (K931896) | Lafayette Pharmacal, Inc. | 1993-08-26 |
| 4 SURE TM ENEMA BAG SET (K922398) | Boston Pacific Medical, Inc. | 1993-06-17 |
| ENEMA KIT (K913620) | York County Blind Center | 1991-11-01 |
| ENEMA BULB (K904534) | R.A.C., Inc. | 1990-12-21 |
| ENEMA BUCKET SET (K901179) | Orion Life Systems, Inc. | 1990-06-28 |
| ENEMA BAG SET (K901182) | Orion Life Systems, Inc. | 1990-06-28 |
| ENEMA KIT 'Y' DESIGN (K900847) | Custom Medical Products, Ltd. | 1990-04-13 |
| ENEMA KIT 'STRAIGHT' DESIGN (K900848) | Custom Medical Products, Ltd. | 1990-04-13 |
| GENT-L-KARE CLEANSING ENEMA SET (K881218) | Geneva Laboratories, Inc. | 1988-07-28 |
| SPS SUSPENSION ENEMA KIT (K872992) | Carolina Medical Products Co. | 1987-09-17 |
| THE LAHR BALLOON (K870019) | Plasco, Inc. | 1987-04-01 |
Recalls involving this device
No recalls on record reference this clearance.