The following data is part of a premarket notification filed by Naturopathic Laboratories International, Inc. with the FDA for Nature's Chemist Pain Relief Ointment And Therapeutic Ultrasound Coupling Agent.
| Device ID | K000604 |
| 510k Number | K000604 |
| Device Name: | NATURE'S CHEMIST PAIN RELIEF OINTMENT AND THERAPEUTIC ULTRASOUND COUPLING AGENT |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | NATUROPATHIC LABORATORIES INTERNATIONAL, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Contact | Emalee G Murphy |
| Correspondent | Emalee G Murphy NATUROPATHIC LABORATORIES INTERNATIONAL, INC. 1900 K STREET, N.W. Washington, DC 20006 -1108 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-23 |
| Decision Date | 2000-05-23 |