DELTA

Sterilizer, Steam

PELTON & CRANE CO.

The following data is part of a premarket notification filed by Pelton & Crane Co. with the FDA for Delta.

Pre-market Notification Details

• Device ID: K945117
• 510k Number: K945117
• Device Name: DELTA
• Classification: Sterilizer, Steam
• Applicant: PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800
• Contact: Kristi Kunkel
• Correspondent: Kristi Kunkel; PELTON & CRANE CO. P.O. BOX 7800 Charlotte, NC 28241 -7800
• Product Code: FLE
• CFR Regulation Number: 880.6880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-10-18
• Decision Date: 1997-02-28