The following data is part of a premarket notification filed by Lhasa Oms, Inc. with the FDA for Pointer Plus.
Device ID | K060508 |
510k Number | K060508 |
Device Name: | POINTER PLUS |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
Contact | Mark W Sheehan |
Correspondent | Mark W Sheehan LHASA OMS, INC. 230 LIBBEY PKWY. Weymouth, MA 02189 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-02-27 |
Decision Date | 2006-06-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
14897076720047 | K060508 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
POINTER PLUS 78354414 not registered Dead/Abandoned |
Peachtel USA, Inc. 2004-01-20 |