The following data is part of a premarket notification filed by Acmi Corporation with the FDA for Scope Guard Protective Sheath, Model Tel-sh.
| Device ID | K030684 |
| 510k Number | K030684 |
| Device Name: | SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH |
| Classification | Endoscopic Storage Cover |
| Applicant | ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Contact | Frank Fucile |
| Correspondent | Frank Fucile ACMI CORPORATION 136 TURNPIKE RD. Southborough, MA 01772 |
| Product Code | OCU |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-05 |
| Decision Date | 2003-06-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925008014 | K030684 | 000 |