The following data is part of a premarket notification filed by Emerson & Co. S.r.l. with the FDA for Proguard, Rr-1, Rr-2.
| Device ID | K982832 |
| 510k Number | K982832 |
| Device Name: | PROGUARD, RR-1, RR-2 |
| Classification | Patient Examination Glove, Specialty |
| Applicant | EMERSON & CO. S.R.L. PIAZZA DELLA VITTORIA 10/12 Genoa, IT 16121 |
| Contact | Stefano Costigltolo |
| Correspondent | Stefano Costigltolo EMERSON & CO. S.R.L. PIAZZA DELLA VITTORIA 10/12 Genoa, IT 16121 |
| Product Code | LZC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-12 |
| Decision Date | 1998-12-23 |
| Summary: | summary |