The following data is part of a premarket notification filed by Carolina Medical Products Co. with the FDA for Sps Suspension Enema Kit.
| Device ID | K872992 |
| 510k Number | K872992 |
| Device Name: | SPS SUSPENSION ENEMA KIT |
| Classification | Enema Kit |
| Applicant | CAROLINA MEDICAL PRODUCTS CO. C/O BURDITT, BOWLES & RADZIUS 1029 VERMONT AVE N.W., STE 200 Washington, DC 20005 |
| Contact | Donald R Stone |
| Correspondent | Donald R Stone CAROLINA MEDICAL PRODUCTS CO. C/O BURDITT, BOWLES & RADZIUS 1029 VERMONT AVE N.W., STE 200 Washington, DC 20005 |
| Product Code | FCE |
| CFR Regulation Number | 876.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-31 |
| Decision Date | 1987-09-17 |