The following data is part of a premarket notification filed by Valley Forge Scientific Corp. with the FDA for Valley Forge Scien-tens Unit & Access. Lead Wire &.
Device ID | K853992 |
510k Number | K853992 |
Device Name: | VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE & |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
Contact | Jerry L Malis |
Correspondent | Jerry L Malis VALLEY FORGE SCIENTIFIC CORP. P.O. BOX 925 Valley Forge, PA 19482 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-09-27 |
Decision Date | 1986-02-21 |