The following data is part of a premarket notification filed by Certified Safety Mfg., Inc. with the FDA for Certi Heat Instant Heat Compress.
| Device ID | K940336 |
| 510k Number | K940336 |
| Device Name: | CERTI HEAT INSTANT HEAT COMPRESS |
| Classification | Pack, Hot Or Cold, Disposable |
| Applicant | CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Contact | Howard Gerson |
| Correspondent | Howard Gerson CERTIFIED SAFETY MFG., INC. 1400 CHESTNUT Kansas City, MO 64127 |
| Product Code | IMD |
| CFR Regulation Number | 890.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-25 |
| Decision Date | 1994-03-07 |