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FDA 510(k)

ACE CUSTOM SURGICAL PACK

K-Number: K922648 · 1993-03-20

ApplicantAce Surgical Supply Co., Inc.
Decision Date1993-03-20
Product CodeLRO
Advisory CommitteeSU
DecisionUnknown

Device Summary

ACE CUSTOM SURGICAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Ace Surgical Supply Co., Inc.. It received FDA 510(k) clearance on 1993-03-20 under 510(k) number K922648. The device is classified under product code LRO. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ACE CUSTOM SURGICAL PACK?

ACE CUSTOM SURGICAL PACK is a medical device that received FDA 510(k) clearance on 1993-03-20. The listed applicant is Ace Surgical Supply Co., Inc.. The 510(k) number is K922648.

When did ACE CUSTOM SURGICAL PACK receive FDA 510(k) clearance?

ACE CUSTOM SURGICAL PACK received FDA 510(k) clearance on 1993-03-20, under 510(k) number K922648.

Who is the listed applicant for ACE CUSTOM SURGICAL PACK?

The FDA 510(k) record lists Ace Surgical Supply Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACE CUSTOM SURGICAL PACK?

The FDA product code for ACE CUSTOM SURGICAL PACK is LRO.

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Other records listing Ace Surgical Supply Co., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093518ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEMK092594ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OXK073343ACE SURGICAL SECURE-MINI IMPLANT SYSTEM, MODEL 09-270X-XXK080074ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XXK061397ACE SURGICAL ORTHODONTIC BONE SCREW SYSTEMS, 1.2/1.5 MM X 6MM,8MM, MODEL 454-91001,454-91002 AND 1.2/1.5MM X 6,8,10MM, MK051381ACE SURGICALPLASTER CALCIUM SULFACE HEMIHYDRATE

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Related Devices (Code: LRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K213481Medline General Surgery TrayMedline Industries, Inc.K212258Medline Cardiovascular Procedure KitMedline Industries, Inc.K041080SURGICAL DRAPE KIT - D.I.R.R.A. SRLD.I.R.R.A. S.R.L.K030721QUICK-TAP PARACENTESIS TRAY, KIT & NEEDLEBallard Medical ProductsK023276AMSINO TRACHEOSTOMY CARE TRAYAmsino International, Inc.K980137WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAYWorldwide Medical Technologies, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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