The following data is part of a premarket notification filed by Bioscan, Inc. with the FDA for Spinal Pad.
Device ID | K993684 |
510k Number | K993684 |
Device Name: | SPINAL PAD |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | BIOSCAN, INC. 6 WALDEN RD. Corrales, NM 87048 |
Contact | Butch Smith |
Correspondent | Butch Smith BIOSCAN, INC. 6 WALDEN RD. Corrales, NM 87048 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-11-01 |
Decision Date | 2000-07-19 |