The following data is part of a premarket notification filed by Ortho Pharmaceutical Corp. with the FDA for Microscrape.
| Device ID | K881151 |
| 510k Number | K881151 |
| Device Name: | MICROSCRAPE |
| Classification | Scrapper, Skin Specimen |
| Applicant | ORTHO PHARMACEUTICAL CORP. ROUTE 202, P.O. BOX 300 Raritan, NJ 08869 |
| Contact | Russell J Hume |
| Correspondent | Russell J Hume ORTHO PHARMACEUTICAL CORP. ROUTE 202, P.O. BOX 300 Raritan, NJ 08869 |
| Product Code | LXK |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-17 |
| Decision Date | 1988-04-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MICROSCRAPE 78779870 3173907 Dead/Cancelled |
Raskin, Bernark I. 2005-12-22 |
![]() MICROSCRAPE 73671240 1479502 Dead/Cancelled |
RASKIN, BERNARD I., M.D. 1987-07-10 |