The following data is part of a premarket notification filed by Coast Medical Corp. with the FDA for Coast Medical, Inc. Rectal Probe.
| Device ID | K930930 |
| 510k Number | K930930 |
| Device Name: | COAST MEDICAL, INC. RECTAL PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | COAST MEDICAL CORP. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Contact | Douglas Mongeon |
| Correspondent | Douglas Mongeon COAST MEDICAL CORP. 1060 NORTH BATAVIA UNIT H Orange, CA 92667 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-23 |
| Decision Date | 1994-02-25 |