The following data is part of a premarket notification filed by Mallinckroot, Inc. with the FDA for Foley-temp(tm).
| Device ID | K882130 |
| 510k Number | K882130 |
| Device Name: | FOLEY-TEMP(TM) |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | MALLINCKROOT, INC. HOOK RD. Argyle, NY 12809 |
| Contact | Philip E Wiegert |
| Correspondent | Philip E Wiegert MALLINCKROOT, INC. HOOK RD. Argyle, NY 12809 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-20 |
| Decision Date | 1988-08-09 |