The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for L.a.s.p. Lumbar And Sacral Pad, Reposition. Snap.
Device ID | K896936 |
510k Number | K896936 |
Device Name: | L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP |
Classification | Electrode, Cutaneous |
Applicant | LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
Contact | Lora L Jones |
Correspondent | Lora L Jones LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids, MI 49508 |
Product Code | GXY |
CFR Regulation Number | 882.1320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-12-13 |
Decision Date | 1990-01-22 |