The following data is part of a premarket notification filed by Olympic Medical Corp. with the FDA for Olympic Warm-lamp.
| Device ID | K932881 |
| 510k Number | K932881 |
| Device Name: | OLYMPIC WARM-LAMP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Contact | Joseph P Stefanile |
| Correspondent | Joseph P Stefanile OLYMPIC MEDICAL CORP. 5900 FIRST AVE., SOUTH Seattle, WA 98108 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1994-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830047036 | K932881 | 000 |
| 00382830005470 | K932881 | 000 |
| 00382830005463 | K932881 | 000 |