The following data is part of a premarket notification filed by Vitaphore Corp. with the FDA for Vitapatch Pin Protection Device For Percutaneous.
Device ID | K895920 |
510k Number | K895920 |
Device Name: | VITAPATCH PIN PROTECTION DEVICE FOR PERCUTANEOUS |
Classification | Tape And Bandage, Adhesive |
Applicant | VITAPHORE CORP. 1505 O'BRIEN DR. Menlo Park, CA 94025 |
Contact | Sophia Pesotchinsky |
Correspondent | Sophia Pesotchinsky VITAPHORE CORP. 1505 O'BRIEN DR. Menlo Park, CA 94025 |
Product Code | KGX |
CFR Regulation Number | 880.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-11 |
Decision Date | 1991-06-06 |